Resources Archives - Page 4 of 20

Process Validation Protocol – Pharmaceutical Template PDF PPT XLS

July 26, 2020July 2, 2018 by Renee

Effective process validation contributes significantly to assuring drug quality. The basic principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.

As we have discussed effective process validation contributes significantly to assuring drug quality. The basic principle of quality assurance is that a drug should be produced that is fit for its intended use. Pharmaceutical Process Validation Protocol & Report Format Example PPT PDF is given here for autoclave and sterilization. First let us know what is Pharmaceutical Process Validation. Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. It is mandatory to have a system stock list put in place, the appropriate SOPs in place, and additionally to check the critical techniques and their documentation. Having a powerful efficient Computer System Validation System put in place will help ensure the stability of the electronic documents, allocate resources better and subsequently can yield long run cost discounts to the company.

Approach to Process Validation:

For purposes of this guidance, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific
evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This
guidance describes process validation activities in three stages.
• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Validation Protocol:

A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. This document should give details of critical steps of the manufacturing process that should be measured, the allowable range of variability and the manner in which the system will be tested.
The validation protocol provides a synopsis of what is hoped to be accomplished. The protocol should list the selected process and control parameters, state the number of batches to be included in the study, and specify how the data, once assembled, will be treated for relevance. The date of approval by the validation team should also be noted.
In the case where a protocol is altered or modified after its approval, appropriate reasoning for such a change must be documented.
The validation protocol should be numbered, signed and dated, and should contain as a minimum the following information:
1. Title
2. Objective & Scope
3. Responsibility
4. Protocol Approval
5. Validation Team
6. Product Composition
7. Process Flow Chart
8. Manufacturing Process
9. Review of Equipments / Utilities
10.Review of Raw Materials and Packing Materials
11. Review of Analytical and Batch Manufacturing Records
12. Review of Batch Quantities for Validation (Raw Materials)
13. Review of Batch Quantities for Validation (Packing Materials)
14. HSE Requirements
15. Review of Process Parameters
16. Validation Procedure
17. Sampling Location
18. Documentation
19. Acceptance Criteria
20. Summary
21. Conclusion

Process Validation Protocol – Pharmaceutical Template PDF PPT XLS

PROCESS VALIDATION PROTOCOL -Pharmaceutical (Autoclave)

1. PRE-EXECUTION APPROVAL

Successful completion of this protocol will provide documented evidence that all key aspects of the Autoclave used in LARGE VOLUME PARENTRALS SECTION adheres to appropriate application criteria, comply with standard operating procedures, and meet current Good Manufacturing Practices (cGMP) requirements.

1.1 SIGNATORY LIST

The signature below indicates approval of this protocol and its attachments for execution.

(Name & Designation, Signature, Date, Prepared By, Checked and Reviewed By, Approved By are the rows and columns you need to fill in the signatory list)

	Name & Designation	Signature	Date

PreparedBy

Checkedand Reviewed By

ApprovedBy

1.2 Validation Team

All individuals participating in the execution of this protocol must fill out a row in the table below. with all the details like Name & Designation, Responsibility, Signature & Initial along with the Date of the process.

Prepare the protocol and coordinate the validation study. Generate amendments to the protocol as required
Microbiological validation of the sterilization process. document the microbiological aspects of the study

Protocol training of operators and provide the resources for validation study

3.0 INSTRUCTIONS

3.1. General Instruction
All performers and reviewers must complete qualification forms using the following guidelines:
· Complete all items on a form in full, except the optional comment’s section.
· Document any deviation from defined protocols and expected results. Owner approval of protocol deviations must be documented before final approval signatures can be obtained.
· Write additional comments on an addendum sheet when there is not enough space on a form to accommodate all comments. Use these three steps when adding an addendum sheet.
1. Number the page alphanumerically.
2. Initial and date additions.
3. Insert the addendum sheet behind the original page.
· Make all entries in permanent black or blue ball pen.
3.2 Correcting Entries
If you need to make corrections on a form, use the procedures described below:

3.2.1 Correcting Short Entries

To correct a short entry [such as a single word or test result] on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss entered or incorrect information.
2. Write the correction to the upper right of the original entry.
3. Give brief explanation of change
4. Initial and date the change.

3.2.2 Correcting Long Entries
To correct a long entry or information block on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss entered or incorrect information.
2. Write the correction on a separate addendum page.
3. Give brief explanation of change.
4. Initial and date the changes.
5. Number the page alphanumerically
6. Place the addendum page behind the original page.

3.3 Marking Elements That Are Not Applicable

Mark each element carefully according to the instruments below, so that it will be clear that the element is unnecessary and that you have not skipped or forgotten the element.
1. Draw a diagonal line, bottom left to upper right corner, through the element that is not required.
2. Write the letters NA [Not Applicable], your initials, and the date above the line. Include comments above the line or on the form to document the reason the element is not required.
3. Where NA is indicated as an option, select this field.
The performer and reviewer must sign and date all forms, as usual, even when part or all of the form is marked “NA”.
Note: All original entries must remain legible after any corrections have been made.
3.4 Caution

The following conditions require “re-qualification”;
· When a Instrument modification has been completed, it affects the installation qualification.
· When the software or firmware has been upgraded or changed
· When this Instrument is being removed from where it was originally installed.
3.5 Re-calibration / Re-certification Requirements
The following conditions require “re-calibration / re-certification;
· For a pre-determined period of time or use.
· After any minor service has been done or replacement of parts.
· When this Instrument is being removed from where it was originally installed.

4. RESPONSIBILITIES

4.1 Validation Team

· Prepare and approve the validation protocol.
· Provide training to the personnel regarding protocol execution.
· Assure complete adherence to the protocol during the execution
· Generate amendment to the validation protocol, as required.
· Document any deviations that occur during protocol execution.
· Document Operator SOP Training.
· Provide the resources required in executing the validation protocol.

4.2 PRODUCTION MANAGER
· Review the validation protocol and the final reports

4.3 QUALITY CONTROL/ASSURANCE MANAGER
· Approve the validation protocol and the final reports

5.0 Objectives:

To verify and establish that the Autoclave is working as per recommendations of the manufacturer.
6.0 Scope:

This validation protocol is applicable to the Autoclave intended to be used for steam sterilization in LARGE VOLUME PARENTRALS SECTION.
The protocol will be implemented under the following conditions

§ The validation of sterilization process using saturated steam as the steriliant
§ Prior to the production of a new sterilizer.
§ A change In the load design or weight that would result in a load that is more difficult to sterilize.

7.0 Equipment Identification

Qualification of utilities and equipment generally includes the following activities:
• Selecting utilities and equipment construction materials, operating principles, and performance characteristics based on whether they are appropriate for their specific uses.
• Verifying that utility systems and equipment are built and installed in compliance with the design specifications (e.g., built as designed with proper materials, capacity, and
functions, and properly connected and calibrated).
• Verifying that utility systems and equipment operate in accordance with the process requirements in all anticipated operating ranges.

Equipment Name

Autoclave

Time controller
¨
2
Pressure controller
¨
2
Temperature controller
¨
3
Pressure gauge
¨
4
Safety Valve
¨
5
Thermometer
¨
Completed By:__________________ Date:_____________

Reviewed By:___________________ Date:_____________

8.0 EQUIPMENT DESCRIPTION

The Autoclave intended to be used for steam sterilizations process. It has following specifications:-

S. No.
Parameter
Range
Readability
Check
01
Timer
0—60 min
1 min
¨
02
Pressure
0—60 Lb/inch²
2.0 Lb/inch²
¨
03
Temperature
0 –150°C
0.5°C
¨
8.1 LOAD IDENTIFICATION

Nature of load
1000ml bottles
Quantity of load
2000 Bottles
8.2 STERILIZATATION CYCLE PARAMETERS
Sterilization set point
106°C
Temperature range
106°C +0.5°C
Expose time
45 minutes

8.3 Equipment Used for PROCESS VALIDATION
Equipment
Calibration
Certificate No.
Issue Date
YES
NO
Recording potentiometer
¨
¨
___________
________
Thermocouples & lead wires
¨
¨
___________
________
Biological indicator i.e.
B. stereothermophyllus
¨
¨
___________
________
Completed By:__________________ Date:_____________

Reviewed By:___________________ Date:_____________

9.0 strerilizatation procedure:

§ Place six thermocouples in the load at the slow to heat points as determined
Previously by(Heat Distribution and Heat Penetration studies)
§ Place thermocouples exterior and near to (Penetration TC)and expose to chamber steam distribution TC)
§ Place BIs (Biological Indicators) at each of the slow to heat penetration location.
§ Load autoclave extend TC out of autoclave and attach to potentiometer
§ Position one TC by controller record sensor
§ Close autoclave door
§ Perform, function check of TC .replace if defective.
§ Replace autoclave sensor chart with a new one
§ Check to make sure that cycle parameters are set
§ Set potentiometer for a 3.0 Hours scan cycle.
§ Initiate sterilization cycle and potentiometer cycle at same time
§ Allow cycle to continue until it is completed. Collect all potentiometers, controls and computer control record and place with protocol.
§ Have computer graph results and calculate Fo value. After load has cooled, remove BIs and have tested
§ Incubate BIs in incubator at 55Cº for 48 hrs

10.0 ACCEPTANCE CRITERIA
1- BDS Strip
All four colors segment of the processed indicator are black. If all other critical process parameters such as temperature, pressure and sterilization are in accordance with cycle reference.
2- Bio-Indicator i.e. B. stereothermophyllus
No growth should be observed after incubation for 48 Hours.
10.1 Results
Temperature : 106°C
Pressure : 10 Lb/inch²
Sterilization Time : 30 minutes
1- Evaluation of the BDS strip.

S.#.
Position of Indicator strip
Stick BDS-test indicator strip on
Acceptance Criteria
Results
All four color segment of indicators strip are black
Yes
No
1
¨
¨

2
¨
¨
2- Evaluation of the Bio-indicator i.e. B. stereothermophyllus

S.#.
Position of
B. stereothermophyllus
Acceptance Criteria
Observation
No growth is observed after incubation for 48 Hours
Yes
No
1
Front/top
left
Fornt/bttm
center
Middle
/centleft
¨
¨

2
Middle/
bttmleft
Rare/top
center
Rare/bttm
left
¨
¨

3
Front/top
center
Front/bottm
center
Middle/cent
left
¨
¨

4
Middle/bttm
right
Rare/top
bottom
Rare/bottm
center
¨
¨

5
Front/top
right
Front/
bottmleft
Middle/
center
¨
¨

6
Middle/
Bttm/Cent
Rare/top
right
Rare/bttm
center
¨
¨
All acceptance criteria have been met. Verified By / Date
Yes ____________No _____________ _____________
If No or N/A, explain in Comments.
Comments:_____________________________________________________________

Completed By:__________________ Date:_____________
Reviewed By:________________ Date:_____________
11.0. Incidents/Deviations

To document any discrepancy or variations noted during the execution of the Process Validation Protocol. Any action to be taken to resolve an outstanding issue is to be identified within the incident report.

INCIDENT #
DESCRIPTION OF INCIDENT
RECORDED BY
DATE

COMMENTS:
____________________________________________________________
____________________________________________________________

12.0 FINAL COMMENTS ABOUT PROCESS VALIDATION
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

13.0 SIGNATURE IDENTIFICATION SHEET

This sheet is a record of each individual who signs or initials any page included in this protocol or in the attached document. Each person shall be identified by typed or printed name.

Name Signature and Initials Company

__________________ _________________________ _____________________

__________________ ________________________ _____________________

__________________ _________________________ _____________________
FINAL APPROVAL OF QUALIFICATION
This document certifies that the process of Autoclavation has been validated as specified and complies with Standard Operating Procedures, and satisfies the requirements for cGMPs.
Name & Designation
Signature
Date
Prepared By

Tahir Ibrahim
Quality Assurance Executive

checked and Reviewed By

Abdul Hafeez
Production manager
Approved By
Tajjamal A Qurashi
Manager Quality Control
PROTOCOL TRAINING
Training Session Date : ____________________
Instructor : ____________________
Protocol Reference : ____________________

Name
Title
Signature
Date

PROCESS VALIDATION PROTOCOL -Pharmaceutical Template PDF PPT XLS
In conclusion, there is far to think about about your Computer System Validation system last to a strong inspection. Make every effort to have a system stock list put in place, the appropriate SOPs in place, and additionally to check the critical techniques and their documentation just before a powerful FDA inspection. Again, simply because the FDA can be inspecting the institution for other factors, doesn’t discount the potential the couple need to audit your pc System Validation School. As mentioned, so many of our businesses respective company procedures are carried out by way of electronic systems in this young age of technologies. Therefore, it could be useful to evaluate the Computer Validation Program whether you foresee a strong inspection or otherwise not. Having a powerful efficient Computer System Validation System put in place will help ensure the stability of the electronic documents, allocate resources better and subsequently can yield long run cost discounts to the company.
more information

DOCUMENTATION

Documentation at each stage of the process validation lifecycle is essential for effective communication in complex, lengthy, and multidisciplinary projects. Documentation is important
so that knowledge gained about a product and process is accessible and comprehensible to others involved in each stage of the lifecycle. Information transparency and accessibility are
fundamental tenets of the scientific method. They are also essential to enabling organizational units responsible and accountable for the process to make informed, science-based decisions that
ultimately support the release of a product to commerce.
The degree and type of documentation required by CGMP vary during the validation lifecycle. Documentation requirements are greatest during Stage 2, process qualification, and Stage 3,
continued process verification. Studies during these stages must conform to CGMPs and must be approved by the quality unit in accordance with the regulations .
Viral and impurity clearance studies, even when performed at small scale, also require quality
unit oversight.
CGMP documents for commercial manufacturing (i.e., the initial commercial master batch production and control record and supporting procedures) are key outputs of Stage 1,
process design. We recommend that firms diagram the process flow for the full-scale process.
Process flow diagrams should describe each unit operation, its placement in the overall process, monitoring and control points, and the component, as well as other processing material inputs
(e.g., processing aids) and expected outputs (i.e., in-process materials and finished product). It is also useful to generate and preserve process flow diagrams of the various scales as the process
design progresses to facilitate comparison and decision making about their comparability.

In conclusion, there is far to think about about your Computer System Validation system last to a strong inspection just before a powerful FDA inspection. Again, simply because the FDA can be inspecting the institution for other factors, doesn’t discount the potential the couple need to audit your pc System Validation School. As mentioned, so many of our businesses respective company procedures are carried out by way of electronic systems in this young age of technologies. Therefore, it could be useful to evaluate the Computer Validation Program whether you foresee a strong inspection or otherwise not.

GLOSSARY OF TERMS

2.1 List of Abbreviation

CGMP Current Good Manufacturing Practices
FDA Food and Drug Administration
GAMP Good Automated Manufacturing Practice
GMP Good Manufacturing Practice
IQ Installation Qualification
OQ Operation Qualification

2.2 Definitions

Acceptance Criteria Agreed standards or ranges, which must be achieved.
Critical component A component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on the quality of the product.
Critical Instrument Any instrument that directly affects product safety, purity, or efficacy.
Direct Impact System An engineering system that may have a direct impact on product quality.
Factor Acceptance Test Documenting the performance characteristics of equipment prior to shipment to site.
Impact Assessment The process of evaluating the impact of the operating, controlling alarming and failure conditions of a system on the quality of a product.
Indirect Impact System An engineering system considered not having a direct impact on product quality.
Installation Qualification Documenting the process equipment and ancillary system are constructed and installed according to pre-determined specifications and functional requirements.
No Impact System This is a system that will not have any impact, either directly or indirectly, on product quality. These systems are designed and commissioned following Good engineering Practice only.
Non-critical Component A component within a system where the operation, contact, alarm or failure may have an indirect impact or no impact on the quality of product.
Operating Limits The minimum and /or maximum values that will ensure that product and safety requirements are met.
Operational Qualification Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
Performance Qualification The documented verification that al aspects of a facility, utility or equipment that can affect product quality perform as intended meeting pre-determined acceptance criteria.
Performance Testing The process by which the performance of interdependent system is demonstrated as within the required tolerances, the output of interdependent system is demonstrated as delivering the required duty or capacity, the interdependent functions of system are interdependent to be as specified and appropriate.
Piping and Instrumentation
Diagrams Primary source of design information for utility systems and process equipment. They are used to depict the process flow, equipment configuration, process parameters, instrumentation, and materials of construction. They also are used to perform overall material and energy balances and pressure balances.

Capability of a process: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms. (ISO 9000:2005)

Commercial manufacturing process: The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term commercial manufacturing process does not include clinical trial or treatment IND material.

Concurrent release: Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the lot release criteria established in the protocol, but before the entire study protocol has been executed.

Continued process verification: Assuring that during routine production the process remains in a state of control. Performance indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process or system, also known as performance metrics in some regions. (ICH Q10)

Process design: Defining the commercial manufacturing process based on knowledge gained through development and scale-up activities.

Process qualification: Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing.

Process validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Quality: The degree to which a set of inherent properties of a product, system, or process fulfils requirements. (ICH Q9)

State of control: A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (ICH Q10)

Primary Drinking Water Standards – PDF EPA Magnesium Aluminum – Safe

July 26, 2020June 13, 2018 by Renee

Primary drinking water standards

The standards set by the United States Environmental Protection Agency (EPA) for drinking water quality is denoted by Maximum Contaminant Levels (MCLs). It reveals the legal threshold limit of the substance on the amount allowed in public water systems under the Safe Drinking Water Act. This is measured as a concentration in milligrams or micrograms per litre of water.

For a contaminant to set a Maximum Contaminant Level EPA first determines the amount of contaminant that may be present with no adverse health effects and this determined level is called the Maximum Contaminant Level Goal (MCLG). MCLGs are non-enforceable public health goals. Then the MCL (legally enforced) is set to the nearest possible level of MCLG. The MCL for a contaminant may be higher than the MCLG because

Difficulties in measuring small quantities of a contaminant
Lack of available treatment technologies
If the costs of treatment would outweigh the public health benefits of a lower MCL. In this case, EPA is allowed to select an MCL that balances the cost of treatment with the public health benefits.

A Treatment Technique (TT) is established instead of an MCL for some contaminants. TTs by EPA are enforceable procedures compulsory for drinking water systems to follow in treating their water for a contaminant.

MCLs and TTs when combined are known as “National Primary Drinking Water Regulations” (NPDWRs), or primary standards. As mentioned separately as well as jointly, The National Primary Drinking Water Regulations (NPDWRs) is legally enforceable primary standards and treatment techniques that are applicable for public water systems. To protect public health by limiting the levels of contaminants in drinking water the Primary standards and treatment techniques are maintained.

In some cases of contaminants that may not cause health problems but they cause aesthetic problems with drinking water, such as the presence of unpleasant tastes or odours, or cosmetic problems, such as tooth discolouration there are no legally enforceable limits on their presence in drinking water. However, EPA recommends maximum levels of these contaminants in drinking water since these contaminants directly don’t affect health problems. This is where the “National Secondary Drinking Water Regulations” (NSDWRs) or secondary standards are being practised. For public water systems in Indian states and Tribes, EPA delegates the primary enforcement responsibility called primacy to those who meet certain requirements.

Below is the NPDWRs table shown.

Microorganisms
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Cryptosporidium	zero	TT³	Gastrointestinal illness (such as diarrhea, vomiting, and cramps)	Human and animal fecal waste
Giardia lamblia	zero	TT³	Gastrointestinal illness (such as diarrhea, vomiting, and cramps)	Human and animal fecal waste
Heterotrophic plate count (HPC)	n/a	TT³	HPC has no health effects; it is an analytic method used to measure the variety of bacteria that are common in water. The lower the concentration of bacteria in drinking water, the better maintained the water system is.	HPC measures a range of bacteria that are naturally present in the environment
Legionella	zero	TT³	Legionnaire’s Disease, a type of pneumonia	Found naturally in water; multiplies in heating systems
Total Coliforms (including fecal coliform and E. Coli) Quick reference guide	zero	5.0%⁴	Not a health threat in itself; it is used to indicate whether other potentially harmful bacteria may be present⁵	Coliforms are naturally present in the environment; as well as feces; fecal coliforms and E. coli only come from human and animal fecal waste.
Turbidity	n/a	TT³	Turbidity is a measure of the cloudiness of water. It is used to indicate water quality and filtration effectiveness (such as whether disease-causing organisms are present). Higher turbidity levels are often associated with higher levels of disease-causing microorganisms such as viruses, parasites and some bacteria. These organisms can cause symptoms such as nausea, cramps, diarrhea, and associated headaches.	Soil runoff
Viruses (enteric)	zero	TT³	Gastrointestinal illness (such as diarrhea, vomiting, and cramps)	Human and animal fecal waste

Disinfection By-products Quick reference guide: Stage 1 and 2 Disinfectants and Disinfection By-products Rules
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Bromate	zero	0.010	Increased risk of cancer	By-product of drinking water disinfection
Chlorite	0.8	1.0	Anaemia; infants and young children: nervous system effects	By-product of drinking water disinfection
Haloacetic acids (HAA5)	n/a⁶	0.060	Increased risk of cancer	By-product of drinking water disinfection
Total Trihalomethanes (TTHMs)	–> n/a⁶	========–>–> 0.080	Liver, kidney or central nervous system problems; increased risk of cancer	By-product of drinking water disinfection

Disinfectants Quick reference guide: Stage 1 and 2 Disinfectants and Disinfection Byproducts Rules
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Chloramines (as Cl₂)	MRDLG=4¹	MRDL=4.0¹	Eye/nose irritation; stomach discomfort, anaemia	Water additive used to control microbes
Chlorine (as Cl₂)	MRDLG=4¹	MRDL=4.0¹	Eye/nose irritation; stomach discomfort	Water additive used to control microbes
Chlorine dioxide (as ClO₂)	MRDLG=0.8¹	MRDL=0.8¹	Anaemia; infants and young children: nervous system effects	Water additive used to control microbes

Inorganic Chemicals
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Antimony	0.006	0.006	Increase in blood cholesterol; decrease in blood sugar	Discharge from petroleum refineries; fire retardants; ceramics; electronics; solder
Arsenic Quick reference guide Consumer fact sheet	0	0.010 as of 01/23/06	Skin damage or problems with circulatory systems, and may have increased risk of getting cancer	Erosion of natural deposits; runoff from orchards, runoff from glass and electronics production wastes
Asbestos (fiber > 10 micrometers)	7 million fibers per liter (MFL)	7 MFL	Increased risk of developing benign intestinal polyps	Decay of asbestos cement in water mains; erosion of natural deposits
Barium	2	2	Increase in blood pressure	Discharge of drilling wastes; discharge from metal refineries; erosion of natural deposits
Beryllium	0.004	0.004	Intestinal lesions	Discharge from metal refineries and coal-burning factories; discharge from electrical, aerospace, and defense industries
Cadmium	0.005	0.005	Kidney damage	Corrosion of galvanized pipes; erosion of natural deposits; discharge from metal refineries; runoff from waste batteries and paints
Chromium (total)	0.1	0.1	Allergic dermatitis	Discharge from steel and pulp mills; erosion of natural deposits
Copper	1.3	TT⁷; Action Level=1.3	Short term exposure: Gastrointestinal distress Long term exposure: Liver or kidney damage People with Wilson’s Disease should consult their personal doctor if the amount of copper in their water exceeds the action level	Corrosion of household plumbing systems; erosion of natural deposits
Cyanide (as free cyanide)	0.2	0.2	Nerve damage or thyroid problems	Discharge from steel/metal factories; discharge from plastic and fertilizer factories
Fluoride	4.0	4.0	Bone disease (pain and tenderness of the bones); Children may get mottled teeth	Water additive which promotes strong teeth; erosion of natural deposits; discharge from fertilizer and aluminum factories
Lead Quick reference guide Rule information	zero	TT⁷; Action Level=0.015	Infants and children: Delays in physical or mental development; children could show slight deficits in attention span and learning abilities Adults: Kidney problems; high blood pressure	Corrosion of household plumbing systems; erosion of natural deposits
Mercury (inorganic)	0.002	0.002	Kidney damage	Erosion of natural deposits; discharge from refineries and factories; runoff from landfills and croplands
Nitrate (measured as Nitrogen)	10	10	Infants below the age of six months who drink water containing nitrate in excess of the MCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue-baby syndrome.	Runoff from fertilizer use; leaking from septic tanks, sewage; erosion of natural deposits
Nitrite (measured as Nitrogen)	1	1	Infants below the age of six months who drink water containing nitrite in excess of the MCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue-baby syndrome.	Runoff from fertilizer use; leaking from septic tanks, sewage; erosion of natural deposits
Selenium	0.05	0.05	Hair or fingernail loss; numbness in fingers or toes; circulatory problems	Discharge from petroleum refineries; erosion of natural deposits; discharge from mines
Thallium	0.0005	0.002	Hair loss; changes in blood; kidney, intestine, or liver problems	Leaching from ore-processing sites; discharge from electronics, glass, and drug factories

Organic Chemicals
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Acrylamide	zero	TT⁸	Nervous system or blood problems; increased risk of cancer	Added to water during sewage/wastewater treatment
Alachlor	zero	0.002	Eye, liver, kidney or spleen problems; anemia; increased risk of cancer	Runoff from herbicide used on row crops
Atrazine	0.003	0.003	Cardiovascular system or reproductive problems	Runoff from herbicide used on row crops
Benzene	zero	0.005	Anemia; decrease in blood platelets; increased risk of cancer	Discharge from factories; leaching from gas storage tanks and landfills
Benzo(a)pyrene (PAHs)	zero	0.0002	Reproductive difficulties; increased risk of cancer	Leaching from linings of water storage tanks and distribution lines
Carbofuran	0.04	0.04	Problems with blood, nervous system, or reproductive system	Leaching of soil fumigant used on rice and alfalfa
Carbon tetrachloride	zero	0.005	Liver problems; increased risk of cancer	Discharge from chemical plants and other industrial activities
Chlordane	zero	0.002	Liver or nervous system problems; increased risk of cancer	Residue of banned termiticide
Chlorobenzene	0.1	0.1	Liver or kidney problems	Discharge from chemical and agricultural chemical factories
2,4-D	0.07	0.07	Kidney, liver, or adrenal gland problems	Runoff from herbicide used on row crops
Dalapon	0.2	0.2	Minor kidney changes	Runoff from herbicide used on rights of way
1,2-Dibromo-3-chloropropane (DBCP)	zero	0.0002	Reproductive difficulties; increased risk of cancer	Runoff/leaching from soil fumigant used on soybeans, cotton, pineapples, and orchards
o-Dichlorobenzene	0.6	0.6	Liver, kidney, or circulatory system problems	Discharge from industrial chemical factories
p-Dichlorobenzene	0.075	0.075	Anemia; liver, kidney or spleen damage; changes in blood	Discharge from industrial chemical factories
1,2-Dichloroethane	zero	0.005	Increased risk of cancer	Discharge from industrial chemical factories
1,1-Dichloroethylene	0.007	0.007	Liver problems	Discharge from industrial chemical factories
cis-1,2-Dichloroethylene	0.07	0.07	Liver problems	Discharge from industrial chemical factories
trans-1,2-Dichloroethylene	0.1	0.1	Liver problems	Discharge from industrial chemical factories
Dichloromethane	zero	0.005	Liver problems; increased risk of cancer	Discharge from drug and chemical factories
1,2-Dichloropropane	zero	0.005	Increased risk of cancer	Discharge from industrial chemical factories
Di(2-ethylhexyl) adipate	0.4	0.4	Weight loss, liver problems, or possible reproductive difficulties.	Discharge from chemical factories
Di(2-ethylhexyl) phthalate	zero	0.006	Reproductive difficulties; liver problems; increased risk of cancer	Discharge from rubber and chemical factories
Dinoseb	0.007	0.007	Reproductive difficulties	Runoff from herbicide used on soybeans and vegetables
Dioxin (2,3,7,8-TCDD)	zero	0.00000003	Reproductive difficulties; increased risk of cancer	Emissions from waste incineration and other combustion; discharge from chemical factories
Diquat	0.02	0.02	Cataracts	Runoff from herbicide use
Endothall	0.1	0.1	Stomach and intestinal problems	Runoff from herbicide use
Endrin	0.002	0.002	Liver problems	Residue of banned insecticide
Epichlorohydrin	zero	TT⁸	Increased cancer risk, and over a long period of time, stomach problems	Discharge from industrial chemical factories; an impurity of some water treatment chemicals
Ethylbenzene	0.7	0.7	Liver or kidneys problems	Discharge from petroleum refineries
Ethylene dibromide	zero	0.00005	Problems with liver, stomach, reproductive system, or kidneys; increased risk of cancer	Discharge from petroleum refineries
Glyphosate	0.7	0.7	Kidney problems; reproductive difficulties	Runoff from herbicide use
Heptachlor	zero	0.0004	Liver damage; increased risk of cancer	Residue of banned termiticide
Heptachlor epoxide	zero	0.0002	Liver damage; increased risk of cancer	Breakdown of heptachlor
Hexachlorobenzene	zero	0.001	Liver or kidney problems; reproductive difficulties; increased risk of cancer	Discharge from metal refineries and agricultural chemical factories
Hexachlorocyclopentadiene	0.05	0.05	Kidney or stomach problems	Discharge from chemical factories
Lindane	0.0002	0.0002	Liver or kidney problems	Runoff/leaching from insecticide used on cattle, lumber, gardens
Methoxychlor	0.04	0.04	Reproductive difficulties	Runoff/leaching from insecticide used on fruits, vegetables, alfalfa, livestock
Oxamyl (Vydate)	0.2	0.2	Slight nervous system effects	Runoff/leaching from insecticide used on apples, potatoes, and tomatoes
Polychlorinated biphenyls (PCBs)	zero	0.0005	Skin changes; thymus gland problems; immune deficiencies; reproductive or nervous system difficulties; increased risk of cancer	Runoff from landfills; discharge of waste chemicals
Pentachlorophenol	zero	0.001	Liver or kidney problems; increased cancer risk	Discharge from wood preserving factories
Picloram	0.5	0.5	Liver problems	Herbicide runoff
Simazine	0.004	0.004	Problems with blood	Herbicide runoff
Styrene	0.1	0.1	Liver, kidney, or circulatory system problems	Discharge from rubber and plastic factories; leaching from landfills
Tetrachloroethylene	zero	0.005	Liver problems; increased risk of cancer	Discharge from factories and dry cleaners
Toluene	1	1	Nervous system, kidney, or liver problems	Discharge from petroleum factories
Toxaphene	zero	0.003	Kidney, liver, or thyroid problems; increased risk of cancer	Runoff/leaching from insecticide used on cotton and cattle
2,4,5-TP (Silvex)	0.05	0.05	Liver problems	Residue of banned herbicide
1,2,4-Trichlorobenzene	0.07	0.07	Changes in adrenal glands	Discharge from textile finishing factories
1,1,1-Trichloroethane	0.20	0.2	Liver, nervous system, or circulatory problems	Discharge from metal degreasing sites and other factories
1,1,2-Trichloroethane	0.003	0.005	Liver, kidney, or immune system problems	Discharge from industrial chemical factories
Trichloroethylene	zero	0.005	Liver problems; increased risk of cancer	Discharge from metal degreasing sites and other factories
Vinyl chloride	zero	0.002	Increased risk of cancer	Leaching from PVC pipes; discharge from plastic factories
Xylenes (total)	10	10	Nervous system damage	Discharge from petroleum factories; discharge from chemical factories

Primary drinking water standards

Radio nuclides Quick Reference Guide
Contaminant	MCLG¹(mg/L)²	MCL or TT¹(mg/L)²	Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)	Sources of Contaminant in Drinking Water
Alpha particles	none ———- zero	15 picocuries per Litre (pCi/L)	Increased risk of cancer	Erosion of natural deposits of certain minerals that are radioactive and may emit a form of radiation known as alpha radiation
Beta particles and photon emitters	none ———- zero	4 millirems per year	Increased risk of cancer	Decay of natural and man-made deposits of certain minerals that are radioactive and may emit forms of radiation known as photons and beta radiation
Radium 226 and Radium 228 (combined)	none ———- zero	5 pCi/L	Increased risk of cancer	Erosion of natural deposits
Uranium	zero	30 ug/L as of 12/08/03	Increased risk of cancer, kidney toxicity	Erosion of natural deposits

Notes

¹Definitions:

Maximum Contaminant Level Goal (MCLG) – The level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety and are non-enforceable public health goals.
Maximum Contaminant Level (MCL) – The highest level of a contaminant that is allowed in drinking water. MCLs are set as close to MCLGs as feasible using the best available treatment technology and taking cost into consideration. MCLs are enforceable standards.
Maximum Residual Disinfectant Level Goal (MRDLG) – The level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.
Treatment Technique (TT) – A required process intended to reduce the level of a contaminant in drinking water.
Maximum Residual Disinfectant Level (MRDL) – The highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control of microbial contaminants.

²Units are in milligrams per liter (mg/L) unless otherwise noted. Milligrams per liter are equivalent to parts per million (PPM).
³EPA’s surface water treatment rules require systems using surface water or ground water under the direct influence of surface water to

Disinfect their water, and
Filter their water, or
Meet criteria for avoiding filtration so that the following contaminants are controlled at the following levels:

Cryptosporidium: Unfiltered systems are required to include Cryptosporidium in their existing watershed control provisions
Giardia lamblia: 99.9% removal/inactivation.
Viruses: 99.99% removal/inactivation.
Legionella: No limit, but EPA believes that if Giardia and viruses are removed/inactivated, according to the treatment techniques in the Surface Water Treatment Rule, Legionella will also be controlled.
Turbidity: For systems that use conventional or direct filtration, at no time can turbidity (cloudiness of water) go higher than 1 Nephelometric Turbidity Unit (NTU), and samples for turbidity must be less than or equal to 0.3 NTUs in at least 95 percent of the samples in any month. Systems that use filtration other than the conventional or direct filtration must follow state limits, which must include turbidity at no time exceeding 5 NTUs.
Heterotrophic Plate Count (HPC): No more than 500 bacterial colonies per milliliter.
Long Term 1 Enhanced Surface Water Treatment: Surface water systems or groundwater under the direct influence (GWUDI) systems serving fewer than 10,000 people must comply with the applicable Long Term 1 Enhanced Surface Water Treatment Rule provisions (such as turbidity standards, individual filter monitoring, Cryptosporidium removal requirements, updated watershed control requirements for unfiltered systems).
Long Term 2 Enhanced Surface Water Treatment Rule: This rule applies to all surface water systems or ground water systems under the direct influence of surface water. The rule targets additionalCryptosporidium treatment requirements for higher risk systems and includes provisions to reduce risks from uncovered finished water storage facilities and to ensure that the systems maintain microbial protection as they take steps to reduce the formation of disinfection byproducts.
Filter Backwash Recycling: This rule requires systems that recycle to return specific recycle flows through all processes of the system’s existing conventional or direct filtration system or at an alternate location approved by the state.

⁴ No more than 5.0% samples total coliform-positive (TC-positive) in a month. (For water systems that collect fewer than 40 routine samples per month, no more than one sample can be total coliform-positive per month.) Every sample that has total coliform must be analyzed for either fecal coliforms or E. coli if two consecutive TC-positive samples, and one is also positive for E.coli fecal coliforms, system has an acute MCL violaton.

⁵ Fecal coliform and E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Disease-causing microbes (pathogens) in these wastes can cause diarrhea, cramps, nausea, headaches, or other symptoms. These pathogens may pose a special health risk for infants, young children, and people with severely compromised immune systems.

⁶ Although there is no collective MCLG for this contaminant group, there are individual MCLGs for some of the individual contaminants:

Trihalomethanes: bromodichloromethane (zero); bromoform (zero); dibromochloromethane (0.06 mg/L): chloroform (0.07 mg/L.
Haloacetic acids: dichloroacetic acid (zero); trichloroacetic acid (0.02 mg/L); monochloroacetic acid (0.07mg/L). Bromoacetic acid and dibromoacetic acid are regulated with this group but have no MCLGs.

⁷ Lead and copper are regulated by a treatment technique that requires systems to control the corrosiveness of their water. If more than 10% of tap water samples exceed the action level, water systems must take additional steps. For copper, the action level is 1.3 mg/L, and for lead is 0.015 mg/L.

⁸ Each water system must certify, in writing, to the state (using third-party or manufacturer’s certification) that when acrylamide and epichlorohydrin are used to treat water, the combination (or product) of dose and monomer level does not exceed the levels specified, as follows:

Acrylamide = 0.05% dosed at 1 mg/L (or equivalent)
Epichlorohydrin = 0.01% dosed at 20 mg/L (or equivalent)

CMO – How to Set Up Pharmaceutical Contract-Manufacturing-Organization ??

July 26, 2020June 10, 2018 by Renee

Pharmaceutical-contract-manufacturing organization setup

A contract manufacturing organization (CMO) is a company that serves other companies on a contract basis to provide comprehensive services. In the pharmaceutical industry, the service ranges from drug development to drug manufacturing. Nowadays, it is also termed as contract development and manufacturing organization (CDMO), because of a comprehensive single-source provider from drug development through the commercial manufacturers. It is of help in terms of scalability and allows the major companies to focus on drug discovery and drug marketing instead. Global manufacturers are occupying a monster share of the contract manufacturing market with low-cost. Even the highest ranking service providers target a specific technology or dosage form for the promotion of end-to-end continuity. Therefore, specialization may be an effective hedge against the loss of market share. This reflects their efficiency for the outsourcing clients.

CMOs offer:

Pre-formulation
Formulation development
Stability studies
Method development
Pre-clinical and Phase I trial materials
Late-stage clinical trial materials
Formal stability, scale-up, registration batches and commercial production.

CMOs are contract manufacturers but aren’t limited to these services because of their development aspect. For the pharmaceutical market, the outsourcing services providers are used in the form of CMOs and CROs- contract research organizations. In response to the international nature of the pharmaceutical niche, CMOs are called for outsourced services.

Setup strategy

Putting up a manufacturing unit is a big challenge for a layman not having the technical know-how and idea about the market. Carrying out a good technical and market survey would be beneficial. Moreover, depending upon one’s forte and the market demand the following are considered:

The ever-rising competition to be in demand as a constant cost-effective manufacturer
Regulatory compliance & Maintenance cost
Locations are selected based on Land cost, tax-free zones, accessibility to resources/transportation convenience.
Cost factor for faraway places or in government/private industrial zones.

You may choose formulation with a wide market to cover up the cost by having maximum utilization of installed pharmaceutical equipment. For people holding specialization and are sure about its actual application can create a market through the novel product/facility.

Notes

Regulatory checks are most important as its non-compliance seems untrustworthy.
Apply and comply with regulatory bodies country-wise to export products in the Indian Pharmaceutical Association website.
For Export registration, enquire the nearest Directorate General of Foreign Trade office.

Quality Control Executive Interview Questions & Answers QA + QC PDF – Pharma Company Job Interview

July 26, 2020May 31, 2018 by Renee

Quality Control Executive Interview Questions & Answers

The fact is very common and it was observed during research that on average 80% of candidates suffer from Interview Fear / Phobia. At the same time those who are able to overcome the fear of exposure, are certain to be successful in any case. Once you clear the Job Requirement, you have to jot down the probable questions and their answers i.e. what all an interviewer can ask you thus making your own interview study material. While doing this sought help from your friends and seniors who are in similar position or industry. If you practise this exercise seriously, you will be able to find out mostly asked questions and you are ready to prompt 80% of the interview correctly. Quality Control Executive jobs are offered for bachelor’s degree and B. Pharmacy fresher, as well as experienced persons, are eligible to apply.

In the pharmaceutical industry, usually, one should qualify the first round of exam for attending the face to face interview. It also depends on which pharmaceutical company you are applying for. It is very important to understand the job profile and what kind of individual is needed for that position. For that clarity, you have to identify your strengths and weaknesses. It is advisable not to enter into any kind of argument with Interviewer. Accept that the interviewer(s) have more experience, listen carefully to them and never argue to justify your point during the interview. Besides knowledge, organizations prefer to choose people who are honest and also flexible in their approach. Rigidity in approach may cost you your position as the business environment is changing very fast these days.

Before the interview closes, it is better to ask for feedback from interviewer irrespective of how your interview went. With this, the impact becomes Organization members feel that candidate has a seeking attitude and is willing to accept feedback resulting in a favorable impression about the candidate.

Quality Control Executive Interview Questions & Answers

Below some are given to have an idea of what sort of questions one may prepare.

Q/A

What is the difference between quality assurance and quality control?

Quality control is the process of identifying the defect and quality assurance is a process of improvement Quality control is reactive Action quality assurance is a protective action QC is a set of actions. Quality control takes CORRECTIVE ACTION during production,

Quality Assurance takes PREVENTIVE ACTION during development or after production (for completely prevention, if any defect arises)

What is the difference between Quality Assurance, Quality Control and Audit Function?

Quality assurance is a set of activities involved in the processes and Quality control is set of activities involved in product and audit function is nothing but the periodic inspection in the quality system.

What does 6 Sigma represent?

Six Sigma represents the six standard deviations from the mean toward the upper specification limit in a normally distributed sample where an average of 3.4 defects per million is reported to live.

Differentiate between product quality and process quality.

Product quality deals with the given specification of an individual product whereas the process quality deals with the process capability of the process that how much it can be effective to produce the quality products.

What is the maximum Acceptable Tolerance Limit for any product?

It is a TOLERANCE limit which is set by CONSUMER for acceptable any lot, parts, etc, generally within +/-5%

How do you track bug and report through Quality Control dept?

Tracking by sampling process, through
FIR (Final Inspection Report)
FOI (First off Approval Inspection Report)
Patrol Inspection Report

In Quality Assurance Plan & QC, what can be implemented to reduce rework in Acoustic Enclosure for manufacturing company?

Proper machine maintenance,
Consistent quality checks on the product,
Purchasing of quality raw materials,
Training and awareness of the operating procedure of the machine.

Quality Control Executive Interview Questions & Answers QA + QC PDF – Pharma Company Job Interview

When do we use a c-chart?

C chart is used when the item is too complex to analyse the product for confirming or not- confirming and subgroup size is same. It is used to monitor the number of defects per unit

What is meant by risk? How can you avoid the risks?

A risk is the possibility that an unfavourable event may occur. It may be predictable or unpredictable. A risk may have 3 components:

The event that could occur;
The probability that the event will occur;
The impact/consequences of the event that if it occurs.

One can avoid Risk by

Identifying the Risk, 2. Quantifying the risk i.e. by Risk identification & Risk Prioritization. 3. Risk Response Development 4.Risk Resolution & Risk Monitoring.

Here we have provided most commonly asked basic questions for the QCE pharmacy interview. There is no specific pattern/rule for asking the interview questions. As the level goes up the pattern also becomes changed for the particular cases where the candidate has worked in projects’ and sometimes they also may ask about the knowledge of the organization. It’s purely an interviewer choice. These interview related information of QC in pharmacy are based on some experienced interviewees suggestions. Hopefully, it would be of help!

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator PPT PDF

July 26, 2020May 21, 2018 by Renee

Here we see Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator.

What is Friability Testing?

To determine the physical strength of uncoated tablets on exposure to mechanical pressure, Friability test is done. The test can find out the extent of mechanical stress withstandable by the tablets during their manufacturing, distribution and handling processes. Friability testing is an accepted operation across the pharmaceutical industry, and the instrument used to perform this process is called Friabilator or Friability Tester.

PROCEDURE FOR OPERATION AND CLEANING FRIABILATOR

Tablet friability measures the efficiency of friabilator or indicates the formulation suitability along with routine QC functions or measures “dusting”. For a specified period of time, tablets are rotated in a plastic drum. To quantify the amount of surface material that has worn off, a gravimetric determination is made.

The responsibility and the accountability are generally of the Executive Manufacturing, Executive QA and Assistant Manager QA.

CLEANING FRIABILATOR

:

By pressing the button to remove the knob on the shaft.
Pull the outward drum from the shaft carefully. Similarly, remove the inside drum by pulling it outside.
By pulling outside remove the detachable disc from both the drums.
Clean both the drums with a clean cloth.
Remove both the trays. Clean the trays with a clean cloth.
After cleaning, put the drums and trays back on its position.

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator

CORRECT OPERATION:

Check cleanliness of the equipment before switching ON.
The drum will initialize itself to the loading position; the display will show START.
Record the weight of the tablets.

For each tablet weighing up to 0.650 g, take 20 tablets.

For each tablet weighing above 0.650 g, take 10 tablets.

Adjust the counts to 100 by pressing the COUNT Key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).
Confirm the reading by pressing ENTER. To see and confirm the number of counts press COUNT Key. Then press RUN/HALT key to start, check the elapsed count. (Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.)
The test terminates with an audible beep and displaying END and the drum rotates in reverse direction discharging the tablets in the tray.
On removing the trays tablets de- dust and weigh the tablets, note down the weight of the tablets.
Calculate the percentage loss in the weight by using the formula

(Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100)

Conclusion

On completion of the procedure, the samples are moved, wiped-off dust and weighted again. The difference between the weight before and after the test is the Friability and should not exceed 1 %( ideal percentage). In some cases, where the diameter of tablets is greater than 13mm, such tablets are tested on drums at 10° tilt.

Precautions:

Do not hold the drums while rotating.
After testing, destroy the tablets.

Top 5 Free Apps for Pharmacy Students

July 26, 2020May 14, 2018 by Renee

Top 5 Free Apps for Pharmacy Students

We all are acquainted with our smartphones these days. When it comes to mobile applications, not a single domain is left out where the apps are not being developed. Here we are presenting some of the free apps particularly aimed at Pharmacy students and technicians. Please go through their description.

Rx Shortages

This free, open-source, cross-platform mobile application gives health professionals and pharmacy students, alike information about drug search and details in an efficient way. Information in the app comes from the FDA and the ASHSP including current/ resolved shortages, and unavailable drugs shown by date. A crowdsourcing feature enables those to track entries have been viewed most frequently by day, week, month, and year. More tech-savvy pharmacy students can download the code and make changes that suit their needs as it’s from open-source means.

Available for: Android devices, iPhone, iPad, iPod touch

Lexicomp

Fast and reliable answers to medication questions at exact moments. A helpful go-to app for pharmacists and students, offering comprehensive drug information (drug dosing, administration, potential interactions, adverse effects), contraindications for adult, paediatric, geriatric, pregnant and lactating patients. Also, drug interaction screenings, listings of OTC and natural products, and toxicology information are available. The company offers institutional subscriptions hence students should check whether their school has access before signing up the Lexicomp account through the manufacturer’s website.

Available for: iPhone, iPad, iPod touch, Android devices.

Require an annual subscription after the first 30 days of use.

Medscape

This comprehensive drug referencing pharmacy app provides search results for specific drugs (with 8,000 brands to choose from), as well as OTC drugs, herbal supplements and alternative medicines. The Drug Interaction Checker determines mild to severe interactions, of patient safety and accurate recording. A disease reference feature contains information over 4,000 diseases and clinical conditions that can be cross-referenced with the appropriate drugs. It also contains the latest policies and procedures with medical news.

Available for: Android/ Apple

Pocket Pharmacist

Easy drug search using their brand or generic name in order to find out their individual properties and pricing. One will be updated with the new drug summaries and details that are added every month, including dosage information, interactions, precautions, strength recommendations, and side effects. One can even filter the drugs by popularity and effectiveness, ensuring the confidence about the best ways to treat an illness.

Available for: Android/ Apple

iPharmacy

It excels at providing users with the description of medication reminder, pill identifier, and drug search. Information can be read or learned ( recalls and alerts, pharmacies nearby, medication forums). Exemplifies a well organized and information-rich app for healthcare professionals and consumer health where virtually any information on certain drug dosing/warnings/adverse reactions, comparative drug prices, and user-contributed discussion on with a community on specific drugs, preferences, attitudes, and medication monographs or inserts etc.

Available for: Android/ Apple

Though one may find other apps equally of help, it depends upon the choice, convenience of mobile devices on which app they are going to use.

Hope all the users and the readers find this information about apps useful.

GMP Requirements for Pharmaceutical Industry -Good Manufacturing Practice

July 26, 2020April 29, 2018 by Renee

GMP requirements for the Pharmaceutical Industry

Good Manufacturing Practice (GMP) is required for all the manufactured products to ensure their quality standards. GMP is designed to minimize the risks involved in any pharmaceutical production that are not eliminated through testing the final product. The compliance putting product quality first, being the best way to conduct business is widely-accepted. It covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.

For each process, a detailed written procedure is maintained that could affect the quality of the finished product. There are systems providing documented proof that correct procedures are consistently followed every time a product is made.

Each step in the manufacturing process follows these basic principles:-

A clean, controlled and hygienic environment to prevent cross-contamination of the product from adulterants and allergens that may render it unsafe for use.
All the processes must be clearly defined controlled; critical processes are validated to ensure consistency and compliance with specifications. Any changes to the process must be evaluated with those affecting the quality of the drug are validated accordingly.
Trained Operators to carry out the document procedures as instructions and procedures need to be clear and unambiguous applying good documentation practices.
During manufacturing, manual or electronic records be kept demonstrating all the steps required by the defined procedures and instructions taken and the quantity and quality of the food or drug should be as expected. Deviations must be investigated and documented.
Keeping records of manufacturing including distribution process for the complete history of a batch to be traced in a comprehensible and accessible form.
A system must be in place for recalling any batch from sale or supply. Distribution of products shall minimize any risk to their quality.
A proper examination of complaints of marketed products with the investigation of the causes of quality defects. Appropriate measures must be taken with respect to the defective products and prevent recurrence.

GMP Implementation

Good manufacturing practice guidelines include manufacturing, testing, and quality assurance. Many countries have legislated that manufacturers follow GMP procedures guidelines in order to assure that a manufactured product is safe for human consumption or use. The procedure encompasses the following:

Quality Systems
Facilities and Equipment Systems
Materials Systems
Production Systems
Packaging and Labelling Systems
Laboratory Control Systems

B. Pharmacy 3rd Year Subjects & Syllabus – PDF B Pharm Second Year 5 + 6 Semester

July 26, 2020April 2, 2018 by Renee

B. Pharmacy 3^rd Year Subjects and Syllabus

According to reports every year millions of students are joining B. Pharmacy to study Pharmacy as this is one of the finest education degrees. In the 3rd year of B. Pharm degree, every candidate shall be required to work for at least 150 hours spread over four weeks in a Pharmaceutical Industry/Hospital. It includes Production unit, Quality Control department, Quality Assurance department, Analytical laboratory, Chemical manufacturing unit, Pharmaceutical R&D, Hospital (Clinical Pharmacy), Clinical Research Organization, Community Pharmacy, etc. In between the Semester 6 and Semester 7 one shall submit a satisfactory report of such work and certificate duly signed by the authority of training organization to the head of the institute. Hence, let us also get acquainted with some terms related to the Pharmacy profession.

In the Pharmaceutical Industry, pharmacists are employed in manufacturing, product development, research, quality control, quality assurance, marketing, sales and administration. Community/Retail Pharmacy encompasses the practice of pharmacy in community settings or retail outlets. Pharmacists, (themselves become the owner of their own pharmacies) are actively educate patients, maintain and monitor drug records and ensure information resource of the highest calibre. Regulatory Bodies control and regulate medicines for the Drug and Pharmaceutical industry. At the federal or provincial level, posts like drug inspectors, drug controllers, and pharmacist/chief pharmacists at drug testing laboratories and Commissioned officers in Armed Forces are deployed.

The curriculum of the B. Pharm 3rd year is as follows:

B pharm Subjects for 3rd year (Semester 5)

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
MEDICINAL CHEMISTRY-II	45	100
INDUSTRIAL PHARMACY	45	100	4/week	50
PHARMACOLOGY-II	45	100	4/week	50
PHARMACOGNOSY AND PHYTOCHEMISTRY II	45	100	4/week	50
PHARMACEUTICAL JURISPRUDENCE	45	100

Total marks	650

B pharmacy Syllabus for Semester 5

Subject: MEDICINAL CHEMISTRY – II

Theory

Unit I

Antihistaminic agents: Histamine, receptors and their distribution in the Human body

H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium

H2-antagonists: Cimetidine*, Famotidine, Ranitidin.

Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole

Anti-neoplastic agents:

Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil, Busulfan, Thiotepa

Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*, Azathioprine

Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin

Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate

Miscellaneous: Cisplatin, Mitotane

Unit II

Anti-anginal:

Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*, Dipyridamole.

Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.

Diuretics: Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide. Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid. Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride. Osmotic Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril

hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine

hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium nitroprusside, Diazoxide,Minoxidil, Reserpine, Hydralazine hydrochloride.

Unit III

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride,

Amiodarone, Sotalol.

Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol

Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione, clopidogrel

Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan.

Unit IV

Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione, Diethyl stilbestrol.

Drugs for erectile dysfunction: Sildenafil, Tadalafil.

Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol

Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone

Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole.

Unit V

Antidiabetic agents:

Insulin and its preparations

Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride. Biguanides: Metformin.

Thiazolidinediones: Pioglitazone, Rosiglitazone.

Meglitinides: Repaglinide, Nateglinide.

Glucosidase inhibitors: Acrabose, Voglibose.

Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine.

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine,

Propoxycaine, Tetracaine, Benoxinate.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

Subject: INDUSTRIAL PHARMACY

Theory

Practical

Unit I

Preformulation Studies: Introduction to preformulation, goals and objectives, study of

physicochemical characteristics of drug substances.

a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow

properties, solubility profile (pKa, pH, partition coefficient), polymorphism

b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization

BCS classification of drugs & its significant

Application of preformulation considerations in the development of solid, liquid oral and

parenteral dosage forms and its impact on stability of dosage forms.

Unit II

Tablets:

a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems.

Equipments and tablet tooling.

b. Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.

c. Quality control tests: In process and finished product tests

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

Unit III

Capsules:

a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. Size of capsules, Filling, finishing and special techniques of formulation of hard gelatine capsules, manufacturing defects. In process and final product quality control tests for capsules.

b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets

Unit IV

Parenteral Products:

a. Definition, types, advantages and limitations. Preformulation factors and essential equirements, vehicles, additives, importance of isotonicity

b. Production procedure, production facilities and controls, aseptic processing

c. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.

d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.

Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye

drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations

Unit V

Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.

Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.

Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.

1. Preformulation studies on paracetamol/asparin/or any other drug

2. Preparation and evaluation of Paracetamol tablets

3. Preparation and evaluation of Aspirin tablets

4. Coating of tablets- film coating of tables/granules

5. Preparation and evaluation of Tetracycline capsules

6. Preparation of Calcium Gluconate injection

7. Preparation of Ascorbic Acid injection

8. Qulaity control test of (as per IP) marketed tablets and capsules

9. Preparation of Eye drops/ and Eye ointments

10. Preparation of Creams (cold / vanishing cream)

11. Evaluation of Glass containers (as per IP)

]’]999

Subject: PHARMACOLOGY-II

Theory

Practical

Unit I

1. Pharmacology of drugs acting on cardio vascular system

a. Introduction to hemodynamic and electrophysiology of heart.

b. Drugs used in congestive heart failure

c. Anti-hypertensive drugs.

d. Anti-anginal drugs.

e. Anti-arrhythmic drugs.

f. Anti-hyperlipidemic drugs.

Unit II

1. Pharmacology of drugs acting on cardio vascular system

a. Drug used in the therapy of shock.

b. Hematinics, coagulants and anticoagulants.

c. Fibrinolytics and anti-platelet drugs

d. Plasma volume expanders

2. Pharmacology of drugs acting on urinary system

a. Diuretics

b. Anti-diuretics.

Unit III

3. Autocoids and related drugs

a. Introduction to autacoids and classification

b. Histamine, 5-HT and their antagonists.

c. Prostaglandins, Thromboxanes and Leukotrienes.

d. Angiotensin, Bradykinin and Substance P.

e. Non-steroidal anti-inflammatory agents

f. Anti-gout drugs

g. Antirheumatic drugs

Unit IV

5. Pharmacology of drugs acting on endocrine system

a. Basic concepts in endocrine pharmacology.

b. Anterior Pituitary hormones- analogues and their inhibitors.

c. Thyroid hormones- analogues and their inhibitors.

d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and

Vitamin-D.

d. Insulin, Oral Hypoglycemic agents and glucagon.

e. ACTH and corticosteroids.

Unit V

5. Pharmacology of drugs acting on endocrine system

a. Androgens and Anabolic steroids.

b. Estrogens, progesterone and oral contraceptives.

c. Drugs acting on the uterus.

6. Bioassay

a. Principles and applications of bioassay.

b. Types of bioassay

c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-tubocurarine, digitalis, histamine and 5-HT.

1. Introduction to in-vitro pharmacology and physiological salt solutions.

2. Effect of drugs on isolated frog heart.

3. Effect of drugs on blood pressure and heart rate of dog.

4. Study of diuretic activity of drugs using rats/mice.

5. DRC of acetylcholine using frog rectus abdominis muscle.

6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus abdominis muscle and rat ileum respectively.

7. Bioassay of histamine using guinea pig ileum by matching method.

8. Bioassay of oxytocin using rat uterine horn by interpolation method.

9. Bioassay of serotonin using rat fundus strip by three point bioassay.

10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.

11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds plot method).

12. Determination of PD2 value using guinea pig ileum.

13. Effect of spasmogens and spasmolytics using rabbit jejunum.

14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.

15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated

experiments by softwares and videos

Subject: PHARMACOGNOSY AND PHYTOCHEMISTRY II

Theory

Practical

Unit I

Metabolic pathways in higher plants and their determination

a) Brief study of basic metabolic pathways and formation of different secondary metabolites

through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.

b) Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.

Unit II

General introduction, composition, chemistry & chemical classes, biosources, therapeutic

uses and commercial applications of following

secondary metabolites:

Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,

Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta

Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis

Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander

Tannins: Catechu, Pterocarpus

Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony

Glycosides: Senna, Aloes, Bitter Almond

Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

Unit III

Isolation, Identification and Analysis of Phytoconstituents

a) Terpenoids: Menthol, Citral, Artemisin

b) Glycosides: Glycyrhetinic acid & Rutin

c) Alkaloids: Atropine, Quinine, Reserpine, Caffeine

d) Resins: Podophyllotoxin, Curcumin

Unit IV

Industrial production, estimation and utilization of the following phytoconstituents: Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and Vinblastine

Unit V

Basics of Phytochemistry

Modern methods of extraction, application of latest techniques like Spectroscopy,

chromatography and electrophoresis in the isolation, purification and identification of crude

drugs

1. Morphology, histology and powder characteristics & extraction & detection of:

Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander

2. Exercise involving isolation & detection of active principles

a. Caffeine – from tea dust.

b. Diosgenin from Dioscorea

c. Atropine from Belladonna

d. Sennosides from Senna

3. Separation of sugars by Paper chromatography

4. TLC of herbal extract

5. Distillation of volatile oils and detection of phytoconstitutents by TLC

6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii)

Colophony (iv) Aloes (v) Myrrh

Subject: PHARMACEUTICAL JURISPRUDENCE

Theory

Unit I

Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,

Conditions for grant of license and conditions of license for manufacture of drugs,

Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan

license and repacking license.

Unit II

Drugs and Cosmetics Act, 1940 and its rules 1945.

Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)

Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties

Labeling & Packing of drugs- General labeling requirements and specimen labels for

drugs and cosmetics, List of permitted colors. Offences and penalties.

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs

Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing

authorities, controlling authorities, Drugs Inspectors

Unit III

· Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its

constitution and functions, Education Regulations, State and Joint state pharmacy

councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

· Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing,

Manufacture In bond and Outside bond, Export of alcoholic preparations,

Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.

· Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives,

Definitions, Authorities and Officers, Constitution and Functions of narcotic &

Psychotropic Consultative Committee, National Fund for Controlling the Drug

Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production

of poppy straw, manufacture, sale and export of opium, Offences and Penalties

Unit IV

· Study of Salient Features of Drugs and Magic Remedies Act and its

rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of

Exempted advertisements, Offences and Penalties

· Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional

Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of

Animals, Performance of Experiments, Transfer and acquisition of animals for

experiment, Records, Power to suspend or revoke registration, Offences and Penalties

· National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)-

2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations,

Retail price and ceiling price of scheduled formulations, National List of Essential

Medicines (NLEM)

Unit V

· Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry

committee, Health survey and development committee, Hathi committee and Mudaliar committee

· Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his job, trade,

medical profession and his profession, Pharmacist’s oath

· Medical Termination of Pregnancy Act

· Right to Information Act

· Introduction to Intellectual Property Rights (IPR)

B Pharm Subjects for Semester 6

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
MEDICINAL CHEMISTRY-III	45	100	4/week	50
PHARMACOLOGY-III	45	100	4/week	50
HERBAL DRUG TECHNOLOGY	45	100	4/week	50
BIOPHARMACEUTICS AND PHARMACOKINETICS	45	100	–	–
PHARMACEUTICAL BIOTECHNOLOGY	45	100	–	–
PHARMACEUTICAL QUALITY ASSURANCE	45	100	–	–

Total marks	750

B pharmacy Syllabus for Semester 6

Subject: MEDICINAL CHEMISTRY – III

Theory

Practical

Unit I

Antibiotics

Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes.

β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors,

Monobactams

Aminoglycosides: Streptomycin, Neomycin, Kanamycin

Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline, Minocycline, Doxycyclin

Unit II

Antibiotics

Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes.

Macrolide: Erythromycin Clarithromycin, Azithromycin.

Miscellaneous: Chloramphenicol*, Clindamycin.

Prodrugs: Basic concepts and application of prodrugs design.

Antimalarials: Etiology of malaria.

Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,

Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.

Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.

Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.

Unit III

Anti-tubercular Agents

Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol, Pyrazinamide, Para amino salicylic acid.*

Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine Streptomycine, Capreomycin sulphate.

Urinary tract anti-infective agents

Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin, Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin

Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.

Antiviral agents:

Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir,

Ritonavir.

Unit IV

Antifungal agents:

Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.

Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole, Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole, Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.

Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide, Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.

Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,

Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.

Sulphonamides and Sulfones

Historical development, chemistry, classification and SAR of Sulfonamides:

Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*, Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.

Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.

Sulfones: Dapsone*.

Unit V

Introduction to Drug Design

Various approaches used in drug design.

Physicochemical parameters used in quantitative structure activity relationship (QSAR) such as partition coefficient, Hammet’s electronic

parameter, Tafts steric parameter and Hansch analysis. Pharmacophore modeling and docking techniques.

Combinatorial Chemistry: Concept and applications chemistry: solid phase and solution phase synthesis.

I Preparation of drugs and intermediates

1 Sulphanilamide

2 7-Hydroxy, 4-methyl coumarin

3 Chlorobutanol

4 Triphenyl imidazole

5 Tolbutamide

6 Hexamine

II Assay of drugs

1 Isonicotinic acid hydrazide

2 Chloroquine

3 Metronidazole

4 Dapsone

5 Chlorpheniramine maleate

6 Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by Microwave irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen bond donors and acceptors for class of drugs course content using drug design software Drug likeliness screening (Lipinskies RO5)

B Pharm Subject: PHARMACOLOGY-III

Theory

Practical

Unit I

1. Pharmacology of drugs acting on Respiratory system

a. Anti -asthmatic drugs

b. Drugs used in the management of COPD

c. Expectorants and antitussives

d. Nasal decongestants

e. Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract

a. Antiulcer agents.

b. Drugs for constipation and diarrhoea.

c. Appetite stimulants and suppressants.

d. Digestants and carminatives.

e. Emetics and anti-emetics.

Unit II

3. Chemotherapy

a. General principles of chemotherapy.

b. Sulfonamides and cotrimoxazole.

c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolins, tetracycline and aminoglycosides.

Unit III

3. Chemotherapy

a. Antitubercular agents

b. Antileprotic agents

c. Antifungal agents

d. Antiviral drugs

e.Anthelmintics

f. Antimalarial drugs

g. Antiamoebic agents

Unit IV

3. Chemotherapy

l. Urinary tract infections and sexually transmitted diseases.

m. Chemotherapy of malignancy.

4. Immunopharmacology

a. Immunostimulants

b. Immunosuppressant

Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

Unit V

5. Principles of toxicology

a. Definition and basic knowledge of acute, subacute and chronic toxicity.

b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicity

c. General principles of treatment of poisoning

d. Clinical symptoms and management of barbiturates, morphine, organophosphosphorus compound and lead, mercury and arsenic poisoning.

6. Chronopharmacology

a. Definition of rhythm and cycles.

b. Biological clock and their significance leading to chronotherapy.

1. Dose calculation in pharmacological experiments

2. Antiallergic activity by mast cell stabilization assay

3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and NSAIDS induced ulcer model.

4. Study of effect of drugs on gastrointestinal motility

5. Effect of agonist and antagonists on guinea pig ileum

6. Estimation of serum biochemical parameters by using semi- auto analyser

7. Effect of saline purgative on frog intestine

8. Insulin hypoglycemic effect in rabbit

9. Test for pyrogens ( rabbit method)

10. Determination of acute oral toxicity (LD50) of a drug from a given data

11. Determination of acute skin irritation / corrosion of a test substance

12. Determination of acute eye irritation / corrosion of a test substance

13. Calculation of pharmacokinetic parameters from a given data

14. Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)

15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon

Signed Rank test)

*Experiments are demonstrated by simulated experiments/videos

Subject: HERBAL DRUG TECHNOLOGY

Theory

Practical

Unit I

Herbs as raw materials

Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation.

Source of Herbs

Selection, identification and authentication of herbal materials.

Processing of herbal raw material

Biodynamic Agriculture

Good agricultural practices in cultivation of medicinal plants including Organic farming.

Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.

Indian Systems of Medicine

a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy.

b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika,Churna, Lehya and Bhasma.

Unit II

Nutraceuticals

General aspects, Market, growth, scope and types of products available in the market. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and various Gastro intestinal diseases.

Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina

Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification. Study of following drugs and their possible side effects and interactions:

Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.

Unit III

Herbal Cosmetics

Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skincare, hair care and oral hygiene products.

Herbal excipients:

Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations :

Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes

Unit IV

Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs. Stability testing of herbal drugs.

Patenting and Regulatory requirements of natural products:

a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy

b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.

Regulatory Issues – Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs – Schedule Z of Drugs & Cosmetics Act for ASU drugs.

Unit V

General Introduction to Herbal Industry

Herbal drugs industry: Present scope and future prospects.

A brief account of plant based industries and institutions involved in work on medicinal and aromatic plants in India.

Schedule T – Good Manufacturing Practice of Indian systems of medicine

Components of GMP (Schedule – T) and its objectives

Infrastructural requirements, working space, storage area, machinery and equipments, standard operating procedures, health and hygiene, documentation and records.

1. To perform preliminary phytochemical screening of crude drugs.

2. Determination of the alcohol content of Asava and Arista

3. Evaluation of excipients of natural origin

4. Incorporation of prepared and standardized extract in cosmetic formulations like creams, lotions and shampoos and their evaluation.

5. Incorporation of prepared and standardized extract in formulations like syrups, mixtures and tablets and their evaluation as per Pharmacopoeial requirements.

6. Monograph analysis of herbal drugs from recent Pharmacopoeias

7. Determination of Aldehyde content

8. Determination of Phenol content

9. Determination of total alkaloids

Subject: BIOPHARMACEUTICS AND PHARMACOKINETICS

Theory

Unit I

Introduction to Bio pharmaceutics

Absorption; Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT, absorption of drug from Non per oral extra-vascular routes, Distribution Tissue permeability of drugs, binding of drugs, apparent, volume of drug distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs

Unit II

Elimination: Drug metabolism and basic understanding metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal routes of drug excretion of drugs

Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in-vitro–in-vivo correlations, bioequivalence studies, methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.

Unit III

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment models, Non compartment models, physiological models, One compartment open model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra vascular administrations. Pharmacokinetics parameters – KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations, understanding of their significance and

application

Unit IV

Multicompartment models: Two compartment open model. IV bolus, Kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their significance in clinical settings.

Unit V

Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. c. Michaelis-menton method of estimating parameters, Explanation with example of drugs.

Subject: PHARMACEUTICAL BIOTECHNOLOGY

Theory

Unit I

a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.

b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.

c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.

d) Brief introduction to Protein Engineering.

e) Use of microbes in industry. Production of Enzymes- General consideration –

Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.

f) Basic principles of genetic engineering.

Unit II

a) Study of cloning vectors, restriction endonucleases and DNA ligase.

b) Recombinant DNA technology. Application of genetic engineering in medicine.

c) Application of r DNA technology and genetic engineering in the production of:

i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.

d) Brief introduction to PCR

Unit III

Types of immunity- humoral immunity, cellular immunity

a) Structure of Immunoglobulins

b) Structure and Function of MHC

c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.

d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum-immune blood derivatives and other products relative to immunity.

e) Storage conditions and stability of official vaccines

f) Hybridoma technology- Production, Purification and Applications

g) Blood products and Plasma Substituties.

Unit IV

a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting.

b) Genetic organization of Eukaryotes and Prokaryotes

c) Microbial genetics including transformation, transduction, conjugation, plasmids and transposons.

d) Introduction to Microbial biotransformation and applications.

e) Mutation: Types of mutation/mutants.

Unit V

a) Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.

b) Large scale production fermenter design and its various controls.

c) Study of the production of – penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin,

d) Blood Products: Collection, Processing and Storage of whole human blood, dried human plasma, plasma Substituties.

Subject: BP606TPHARMACEUTICAL QUALITY ASSURANCE

Theory

Unit I

Quality Assurance and Quality Management concepts: Definition and concept of Quality

control, Quality assurance and GMP

Total Quality Management (TQM): Definition, elements, philosophies

ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,

with special emphasis on Q-series guidelines, ICH stability testing guidelines

Quality by design (QbD): Definition, overview, elements of QbD program, tools

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration

NABL accreditation : Principles and procedures

Unit II

Organization and personnel: Personnel responsibilities, training, hygiene and personal records.

Premises: Design, construction and plant layout, maintenance, sanitation, environmental

control, utilities and maintenance of sterile areas, control of contamination.

Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

Unit III

Quality Control: Quality control test for containers, rubber closures and secondary packing

materials.

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,

Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities

Unit IV

Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal.

Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records.

Unit V

Calibration and Validation: Introduction, definition and general principles of calibration,

qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.

Warehousing: Good warehousing practice, materials management

Pharmacy market demand

Hospitals: In abroad mostly, the Doctors diagnose but the pharmacists decide the medicines and their dosage. Therefore, Pharmacy graduates have an important role in earning attractive remuneration and to occupy strategic positions.

Production and Manufacturing: Professionals for production and manufacturing are not only required by biotechnological products, surgical dressings, medical devices, equipment, ayurvedic/ homoeopathic / Unani medicines, veterinary medicine, etc but also for the requirement for the production of cosmetics, soaps, toiletries and dental products.

Analysis and Testing: Highly skilled staff is required by companies to handle sensitive analytical dealings and sophisticated equipment. Analysis and testing go hand in hand in order to maintain a proper Quality control (QC) and Quality Assurance (QA).

R & D: M. Pharms and Ph.Ds are highly in demand for research of new drugs, process development, formulation, development, clinical trials and Toxicological Studies

Marketing: Sales and marketing are considered to be a highly technical arena and hence one of the best when it comes to perks.

B. Pharmacy 2nd Year Subjects & Syllabus PDF B Pharm Second Year 3 + 4 Semester

July 26, 2020March 29, 2018 by Renee

B. Pharmacy 2^nd Year Subjects and Syllabus

It’s always good to be knowledgeable about the chosen stream chain. The B. Pharm degree is the basic prerequisite for registration to practice as a pharmacist in many countries. In India, as we came to know that the colleges imparting this educational courses(D. Pharm, B. Pharm, M. Pharm or Pharm. D) has to be approved by Pharmacy Council Of India (PCI) or All Indian Council of Technical Education (AICTE). Similarly, outside India countries those are providing these courses are also affiliated with some universities. Let us check out those and spread the information to the students aspiring for the same.

Apart from the United States, Canadian universities having B. Pharm programs are Dalhousie University, Memorial University of Newfoundland, University of Manitoba and by the University of Saskatchewan. In Australia, all B. Pharm programs are accredited by the New Zealand and Australian Pharmacy Schools Accreditation Committee (NAPSAC). B. Pharm (Rural) program was offered by the University of Sydney (Camperdown/Darlington campus). Hong Kong provides the Bachelor of Pharmacy course offered by the Chinese University of Hong Kong (CUHK) under the Faculty of Medicine. The Bachelor of Pharmacy degree in Bangladesh is approved by the Pharmacy Council of Bangladesh (PCB). In Norway, Oslo Metropolitan University, The University of Tromso and Nord University offer the B. Pharm degree. B. Pharm programs in Africa are offered at the National University of Lesotho – Department of Pharmacy, by some Ugandan universities and Kenyan universities too. Many universities in South Africa also accredit B. Pharm programs.

Here we are providing the syllabus of B. Pharm (2nd year). As the lateral entry on the third semester, candidates on completion approved D. Pharmacy course by Pharmacy Council of India can apply accordingly.

B. Pharmacy Subjects for 2nd year (Semester 3)

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
PHARMACEUTICAL ORGANIC CHEMISTRY –II	45	100	4/week	50
PHYSICAL PHARMACEUTICS-I	45	100	4/week	50
PHARMACEUTICAL MICROBIOLOGY	45	100	4/week	50
PHARMACEUTICAL ENGINEERING	45	100	4/week	50

Total marks	600

B. Pharm Syllabus for Semester 3 Second Year

Subject: PHARMACEUTICAL ORGANIC CHEMISTRY –II

Theory

Practical

Unit I

· Benzene and its derivatives

A. Analytical, synthetic and other evidences in the derivation of structure of benzene, Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule

B. Reactions of benzene-nitration, sulphonation, halogenations reactivity,

Friedelcrafts alkylation- reactivity, limitations,

Friedelcrafts acylation.

C. Substituents, effect of substituents on reactivity and orientation of mono substituted benzene compounds towards electrophilic substitution reaction.

D. Structure and uses of DDT, Saccharin, BHC and Chloramine

Unit II

· Phenols* – Acidity of phenols, effect of substituents on acidity, qualitative tests, Structure and uses of phenol, cresols, resorcinol, naphthols

· Aromatic Amines* – Basicity of amines, effect of substituents on basicity, and synthetic uses of aryl diazonium salts

· Aromatic Acids* –Acidity, effect of substituents on acidity and important reactions of benzoic acid.

Unit III

· Fats and Oils

a.Fatty acids – reactions.

b. Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying oils.

c. Analytical constants – Acid value, Saponification value, Ester value,

Iodine value, Acetyl value, Reichert Meissl (RM) value – significance and

principle involved in their determination.

Unit IV

· Polynuclear hydrocarbons:

a. Synthesis, reactions

b. Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene, Diphenylmethane, Triphenylmethane and their derivative

Unit V

· Cyclo alkanes*

Stabilities – Baeyer’s strain theory, limitation of Baeyer’s strain theory, Coulson and Moffitt’s modification, Sachse Mohr’s theory (Theory of strainless rings), reactions of cyclopropane and cyclobutane only

I. Experiments involving laboratory techniques

· Recrystallization

· Steam distillation

II. Determination of following oil values (including standardization of

reagents)

· Acid value

· Saponification value

· Iodine value

III. Preparation of compounds

· Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol

/Aniline by acylation reaction.

· 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/

· Acetanilide by halogenation (Bromination) reaction.

· 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid /

Nitro benzene by nitration reaction.

· Benzoic acid from Benzyl chloride by oxidation reaction.

· Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by

hydrolysis reaction.

· 1-Phenyl azo-2-napthol from Aniline by diazotization and coupling

reactions.

· Benzil from Benzoin by oxidation reaction.

· Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction

· Cinnammic acid from Benzaldehyde by Perkin reaction

· P-Iodo benzoic acid from P-amino benzoic acid

Subject: PHYSICAL PHARMACEUTICS-I

Theory

Practical

Unit I

Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions,

ideal solubility parameters, solvation & association, quantitative approach to the factors

influencing solubility of drugs, diffusion principles in biological systems. Solubility

of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions)

Raoult’s law, real solutions. Partiallymiscible liquids, Critical solution temperature and

applications. Distribution law, its limitations and applications

Unit II

States of Matter and properties of matter:State of matter, changes in the state of matter,

latent heats, vapour pressure, sublimation critical point, eutectic mixtures, gases, aerosols

– inhalers, relative humidity, liquid complexes, liquid crystals, glassy states, solid crystalline,

amorphous & polymorphism.

Physicochemical properties of drug molecules: Refractive index, optical rotation,

dielectric constant, dipole moment, dissociation constant, determinations and applications.

Unit III

Surface and interfacial phenomenon: Liquid interface, surface & interfacial tensions,

surface free energy, measurement of surface & interfacial tensions, spreading coefficient,

adsorption at liquid interfaces, surface active agents, HLB Scale, solubilisation, detergency, adsorption at solid interface.

Unit IV

Complexation and protein binding: Introduction, Classification of Complexation,

Applications, methods of analysis, protein binding, Complexation and drug action,

crystalline structures of complexes and thermodynamic treatment of stability constants

Unit V

pH, buffers and Isotonic solutions: Sorensen’s pH scale, pH determination(electrometric and calorimetric), applications of buffers, buffer equation, buffer capacity, buffers in pharmaceutical and biological systems, buffered isotonic solutions

1. Determination the solubility of drug at room temperature

2. Determination of pKa value by Half Neutralization/ Henderson Hasselbalch

equation.

3. Determination of Partition co- efficient of benzoic acid in benzene and water

4. Determination of Partition co- efficient of Iodine in CCl4 and water

5. Determination of % composition of NaCl in a solution using phenol-water system by CST method

6. Determination of surface tension of given liquids by drop count and drop weight method

7. Determination of HLB number of a surfactant by saponification method

8. Determination of Freundlich and Langmuir constants using activated charcoal

9. Determination of critical micellar concentration of surfactants

10. Determination of stability constant and donor acceptor ratio of PABA-Caffeine complex by solubilitymethod

11. Determination of stability constant and donor acceptor ratio of Cupric-Glycine complex by pH titration method

Subject: PHARMACEUTICAL MICROBIOLOGY

Theory

Practical

Unit I

Introduction, history of microbiology, its branches, scope and its

importance.

Introduction to Prokaryotes and Eukaryotes

Study of ultra-structure and morphological classification of bacteria,

nutritional requirements, raw materials used for culture media and physical

parameters for growth, growth curve, isolation and preservation methods

for pure cultures, cultivation of anaerobes, quantitative measurement of

bacterial growth (total & viable count).

Study of different types of phase constrast microscopy, dark field

microscopy and electron microscopy.

Unit II

Identification of bacteria using staining techniques (simple, Gram’s &Acid

fast staining) and biochemical tests (IMViC).

Study of principle, procedure, merits, demerits and applications of physical,chemical gaseous,radiation and mechanical method of sterilization, Evaluation of the efficiency of sterilization methods, Equipments employed in large scale sterilization, Sterility indicators

Unit III

Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses.

Classification and mode of action of disinfectants, Factors influencing disinfection, antiseptics and their evaluation. For

bacteriostatic and bactericidal actions

Evaluation of bactericidal & Bacteriostatic.

Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP

Unit IV

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification.

Principles and methods of different microbiological assay. Methods for

standardization of antibiotics, vitamins and amino acids.

Assessment of a new antibiotic.

Unit V

Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants,

assessment of microbial contamination and spoilage.

Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations.

Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures.

Application of cell cultures in pharmaceutical industry and research.

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology.

2. Sterilization of glassware, preparation and sterilization of media.

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical).

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques.

6. Microbiological assay of antibiotics by cup plate method and other methods

7. Motility determination by Hanging drop method.

8. Sterility testing of pharmaceuticals.

9. Bacteriological analysis of water

10. Biochemical test.

Subject: PHARMACEUTICAL ENGINEERING

Theory

Practical

Unit I

· Flow of fluids: Types of manometers, Reynolds number and its significance,

Bernoulli’s theorem and its applications, Energy losses, Orifice meter, Venturimeter, Pitot tube and Rotometer.

· Size Reduction: Objectives, Mechanisms & Laws governing size reduction, factors affecting size reduction, principles, construction, working, uses, merits and demerits of Hammer mill, ball mill, fluid energy mill, Edge runner mill & end runner mill.

· Size Separation: Objectives, applications & mechanism of size separation,official standards of powders, sieves, size separation Principles, construction, working, uses, merits and demerits of Sieve shaker, cyclone separator, Air separator, Bag filter & elutriation tank microscopy, dark field microscopy and electron microscopy.

Unit II

· Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier’s law, Heat transfer by conduction, convection & radiation. Heat interchangers & heat exchangers.

· Evaporation: Objectives, applications and factors influencing evaporation, differences between evaporation and other heat process. principles, construction, working, uses, merits and demerits of Steam jacketed kettle, horizontal tube evaporator, climbing film evaporator, forced circulation evaporator, multiple effect evaporator& Economy of multiple effect evaporator.

· Distillation: Basic Principles and methodology of simple distillation,flash

distillation, fractional distillation, distillation under reduced pressure, steam distillation & molecular distillation

Unit III

· Drying: Objectives, applications & mechanism of drying process, measurements

& applications of Equilibrium Moisture content, rate of drying curve. principles,

construction, working, uses, merits and demerits of Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer, freeze dryer.

· Mixing: Objectives, applications & factors affecting mixing, Difference between

solid and liquid mixing, mechanism of solid mixing, liquids mixing and semisolids mixing. Principles, Construction, Working, uses, Merits and Demerits of Double cone blender, twin shell blender, ribbon blender, Sigma blade mixer,

planetarymixers, Propellers, Turbines, Paddles & Silverson Emulsifier

Unit IV

· Filtration: Objectives, applications, Theories & Factors influencing filtration, filter aids, filter medias. Principle, Construction, Working, Uses, Merits and demerits of plate & frame filter, filter leaf, rotary drum filter, Meta filter &

Cartridge filter, membrane filters and Seidtz filter.

· Centrifugation: Objectives, principle & applications of Centrifugation, principles, construction, working, uses, merits and demerits of Perforated basket centrifuge, Non-perforated basket centrifuge, semi continuous centrifuge & super centrifuge.

Unit V

· Materials of pharmaceutical plant construction, Corrosion and its prevention: Factors affecting during materials selected for Pharmaceutical plant construction, Theories of corrosion, types of corrosion and there prevention.

Ferrous and nonferrous metals, inorganic and organic non metals, basic of material handling systems.

I. Determination of radiation constant of brass, iron, unpainted and painted glass.

II. Steam distillation – To calculate the efficiency of steam distillation.

III. To determine the overall heat transfer coefficient by heat exchanger.

IV. Construction of drying curves (for calcium carbonate and starch).

V. Determination of moisture content and loss on drying.

VI. Determination of humidity of air – i) From wet and dry bulb temperatures –use of Dew point method.

VII. Description of Construction working and application of Pharmaceutical

Machinery such as rotary tablet machine, fluidized bed coater, fluid energy mill,

de humidifier.

VIII. Size analysis by sieving – To evaluate size distribution of tablet granulations – Construction of various size frequency curves including arithmetic and logarithmic probability plots.

IX. Size reduction: To verify the laws of size reduction using ball mill and

determining Kicks, Rittinger’s, Bond’s coefficients, power requirement and

critical speed of Ball Mill.

X. Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer and such other major equipment.

XI. Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration and Thickness/ viscosity)

XII. To study the effect of time on the Rate of Crystallization.

XIII. To calculate the uniformity Index for given sample by using Double Cone

Blender.

B. Pharmacy Subjects for Semester 4

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
PHARMACEUTICAL ORGANIC CHEMISTRY –III	45	100	–	–
MEDICINAL CHEMISTRY – I	45	100	4/week	50
PHYSI CAL PHARMACEUTICS -II	45	100	3/week	50
PHARMACOLOGY-I	45	100	4/week	50
PHARMACOGNOSY AND PHYTOCHEMISTRY I	45	100	4/week	50

Total marks	700

B. Pharmacy Second Year Syllabus for Semester 4

Subject: PHARMACEUTICAL ORGANIC CHEMISTRY –III

Theory

Unit I

Stereo isomerism

Optical isomerism –Optical activity, enantiomerism, diastereoisomerism, meso compounds, Elements of symmetry, chiral and achiral molecules, DL system of nomenclature of optical isomers, sequence rules, RS system of nomenclature of optical isomers, Reactions of chiral molecules, Racemic modification and resolution of racemic mixture.

Unit II

Geometrical isomerism, Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems), Methods of determination of configuration of geometrical isomers. Conformational isomerism in Ethane, n-Butane and Cyclohexane, Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for optical activity. Stereospecific and stereoselective reactions

Unit III

Heterocyclic compounds:

Nomenclature and classification, Synthesis, reactions and medicinal uses of following compounds/derivatives, Pyrrole, Furan, and Thiophene, Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene

Unit IV

Synthesis, reactions and medicinal uses of following compounds/derivatives.

Pyrazole, Imidazole, Oxazole and Thiazole.

Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine, Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their derivatives

Unit V

Reactions of synthetic importance

Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch reduction, Wolff Kishner reduction. Oppenauer-oxidation and Dakin reaction. Beckmanns rearrangement and Schmidt rearrangement. Claisen-Schmidt condensation

Subject: MEDICINAL CHEMISTRY – I

Theory

Practical

Unit I

Introduction to Medicinal Chemistry, History and development of medicinal chemistry, Physicochemical properties in relation to biological action

Unit II

Drugs acting on Autonomic Nervous System, Adrenergic Neurotransmitters:

Biosynthesis and catabolism of catecholamine. Adrenergic receptors (Alpha & Beta) and their distribution.

Sympathomimetic agents: SAR of Sympathomimetic agents

· Direct acting:

Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine, Methyldopa, Clonidine, Dobutamine, Isoproterenol, Terbutaline, Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline.

· Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine,

Propylhexedrine.

· Agents with mixed mechanism: Ephedrine, Metaraminol.

Adrenergic Antagonists:

Alpha adrenergic blockers: Tolazoline*, Phentolamine,

Phenoxybenzamine, Prazosin, Dihydroergotamine, Methysergide.

Beta adrenergic blockers: SAR of beta blockers, Propranolol*,

Metibranolol, Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol,

Labetolol, Carvedilol.

Unit III

Cholinergic neurotransmitters:

Biosynthesis and catabolism of acetylcholine.

Cholinergic receptors (Muscarinic & Nicotinic) and their distribution.

Parasympathomimetic agents: SAR of Parasympathomimetic agents

Direct acting agents: Acetylcholine, Carbachol*, Bethanechol,

Methacholine, Pilocarpine.

Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible):

Physostigmine, Neostigmine*, Pyridostigmine, Edrophonium chloride,

Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate

iodide, Parathione, Malathion.

Cholinesterase reactivator: Pralidoxime chloride.

Cholinergic Blocking agents: SAR of cholinolytic agents, Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine sulphate, Scopolamine hydrobromide, Homatropine hydrobromide,

Ipratropium bromide*.

Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate

hydrochloride, Clidinium bromide, Dicyclomine hydrochloride*,

Glycopyrrolate, Methantheline bromide, Propantheline bromide, Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine hydrochloride*, Tridihexethyl chloride, Isopropamide iodide,

Ethopropazine hydrochloride.

Unit IV

Drugs acting on Central Nervous System

A. Sedatives and Hypnotics:

Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*,

Oxazepam, Chlorazepate, Lorazepam, Alprazolam, Zolpidem

Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital,

Amobarbital, Butabarbital, Pentobarbital, Secobarbital

Miscelleneous:

Amides & imides: Glutethmide.

Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.

Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.

B. Antipsychotics

Phenothiazeines: SAR of Phenothiazeines – Promazine hydrochloride,

Chlorpromazine hydrochloride*, Triflupromazine, Thioridazine

hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,

Trifluoperazine hydrochloride.

Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene,

Loxapine succinate, Clozapine.

Fluro buterophenones: Haloperidol, Droperidol, Risperidone.

Beta amino ketones: Molindone hydrochloride.

Benzamides: Sulpieride.

C. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant action

Barbiturates: Phenobarbitone, Methabarbital. Hydantoins:

Phenytoin*, Mephenytoin, Ethotoin Oxazolidine diones:

Trimethadione, Paramethadione Succinimides:

Phensuximide, Methsuximide, Ethosuximide* Urea and

monoacylureas: Phenacemide, Carbamazepine*

Benzodiazepines: Clonazepam

Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate

Unit V

General anesthetics:

Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane, Sevoflurane, Isoflurane, Desflurane.

Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal sodium, Thiopental sodium.

Dissociative anesthetics: Ketamine hydrochloride.*

Narcotic and non-narcotic analgesics

Morphine and related drugs: SAR of Morphine analogues, Morphine sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride,

Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl citrate*,

Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine, Levorphanol tartarate.

Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate,

Naloxone hydrochloride.

Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*,

Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac,

Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen, Antipyrine, Phenylbutazone.

I Preparation of drugs/ intermediates

1. 1,3-pyrazole

2. 1,3-oxazole

3. Benzimidazole

4. Benztriazole

5. 2,3- diphenyl quinoxaline

6. Benzocaine

7. Phenytoin

8. Phenothiazine

9. Barbiturate

II Assay of drugs

1. Chlorpromazine

2. Phenobarbitone

3. Atropine

4. Ibuprofen

5. Aspirin

6. Furosemide

III Determination of Partition coefficient for any two drugs

Subject: PHYSICAL PHARMACEUTICS-II

Theory

Practical

Unit I

Colloidal dispersions: Classification of dispersed systems & their general characteristics, size & shapes of colloidal particles, classification of colloids & comparative account of their general properties. Optical, kinetic & electrical properties.

Effect of electrolytes, coacervation, peptization& protective action.

Unit II

Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature,

non-Newtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in

formulation, determination of viscosity, capillary, falling Sphere, rotational viscometers

Deformation of solids: Plastic and elastic deformation, Heckel equation, Stress, Strain,

Elastic Modulus.

Unit III

Coarse dispersion: Suspension, interfacial properties of suspended particles, settling in

suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions and emulsion formulation by HLB method.

Unit IV

Micromeretics: Particle size and distribution, mean particle size, number and weight

distribution, particle number, methods for determining particle size by different

methods, counting and separation method, particle shape, specific surface, methods for

determining surface area, permeability, adsorption, derived properties of powders,

porosity, packing arrangement, densities, bulkiness & flow properties.

Unit V

Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate constants, determination of reaction order. Physical and chemical factors influencing the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant, specific & general acid base catalysis, Simple numerical problems. Stabilization of medicinal agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in expiration dating of pharmaceutical dosage forms. Photolytic degradation and its prevention.

1. Determination of particle size, particle size distribution using sieving method

2. Determination of particle size, particle size distribution using Microscopic method

3. Determination of bulk density, true density and porosity

4. Determine the angle of repose and influence of lubricant on angle of repose

5. Determination of viscosity of liquid using Ostwald’s viscometer

6. Determination sedimentation volume with effect of different suspending agent

7. Determination sedimentation volume with effect of different concentration of single suspending agent

8. Determination of viscosity of semisolid by using Brookfield viscometer

9. Determination of reaction rate constant first order.

10. Determination of reaction rate constant second order

11. Accelerated stability studies

Subject: PHARMACOLOGY-I

Theory

Practical

Unit I

1. General Pharmacology

a. Introduction to Pharmacology- Definition, historical landmarks and scope of

pharmacology, nature and source of drugs, essential drugs concept and routes of

drug administration, Agonists, antagonists( competitive and non competitive), spare

receptors, addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy, allergy.

b. Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and

excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination

Unit II

General Pharmacology

a. Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories and classification of receptors, regulation of receptors. drug receptors interactions signal transduction mechanisms, G-protein–coupled receptors, ion channel receptor,

transmembrane enzyme linked receptors, transmembrane JAK-STAT binding

receptor and receptors that regulate transcription factors, dose response relationship, therapeutic index, combined effects of drugs and factors modifying drug action.

b. Adverse drug reactions.

c. Drug interactions (pharmacokinetic and pharmacodynamic)

d. Drug discovery and clinical evaluation of new drugs -Drug discovery phase, preclinical evaluation phase, clinical trial phase, phases of clinical trials and pharmacovigilance.

Unit III

Pharmacology of drugs acting on peripheral nervous system

a. Organization and function of ANS.

b. Neurohumoral transmission,co-transmission and classification of neurotransmitters.

c. Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.

d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).

e. Local anesthetic agents.

f. Drugs used in myasthenia gravis and glaucoma.

Unit IV

Pharmacology of drugs acting on central nervous system

a. Neurohumoral transmission in the C.N.S, special emphasis on importance of various neurotransmitters like with GABA, Glutamate, Glycine, serotonin, dopamine.

b. General anesthetics and pre-anesthetics.

c. Sedatives, hypnotics and centrally acting muscle relaxants.

d. Anti-epileptics

e. Alcohols and disulfiram

Unit V

Pharmacology of drugs acting on central nervous system

a. Psychopharmacological agents: Antipsychotics, antidepressants, anti-anxiety agents, anti-manics and hallucinogens.

b. Drugs used in Parkinsons disease and Alzheimer’s disease.

c. CNS stimulants and nootropics.

d. Opioid analgesics and antagonists

e. Drug addiction, drug abuse, tolerance and dependence.

1. Introduction to experimental pharmacology.

2. Commonly used instruments in experimental pharmacology.

3. Study of common laboratory animals.

4. Maintenance of laboratory animals as per CPCSEA guidelines.

5. Common laboratory techniques. Blood withdrawal, serum and plasma separation, anesthetics and euthanasia used for animal studies.

6. Study of different routes of drugs administration in mice/rats.

7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping time in mice.

8. Effect of drugs on ciliary motility of frog oesophagus.

9. Effect of drugs on rabbit eye.

10. Effects of skeletal muscle. relaxants using rota-rod apparatus.

11. Effect of drugs on locomotor activity using actophotometer.

12. Anticonvulsant effect of drugs by MES and PTZ method.

13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.

14. Study of anxiolytic activity of drugs using rats/mice.

15. Study of local anesthetics by different methods.

Note: All laboratory techniques and animal experiments are demonstrated by simulated experiments by softwares and videos

Subject: PHARMACOGNOSY AND PHYTOCHEMISTRY I

Theory

Practical

Unit I

Introduction to Pharmacognosy:

(a) Definition, history, scope and development of Pharmacognosy

(b) Sources of Drugs – Plants, Animals, Marine & Tissue culture

mucilages, oleoresins and oleo- gum -resins).

Classification of drugs:

Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero

taxonomical classification of drugs

Quality control of Drugs of Natural Origin:

Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical,

chemical and biological methods and properties.

Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants,

camera lucida and diagrams of microscopic objects to scale with camera lucida.

Unit II

Cultivation, Collection, Processing and storage of drugs of natural origin:

Cultivation and Collection of drugs of natural origin

Factors influencing cultivation of medicinal plants.

Plant hormones and their applications.

Polyploidy, mutation and hybridization with reference to medicinal plants

Conservation of medicinal plants

Unit III

Plant tissue culture:

Historical development of plant tissue culture, types of cultures, Nutritional requirements, growth and their maintenance.

Applications of plant tissue culture in pharmacognosy. Edible vaccines

Unit IV

Pharmacognosy in various systems of medicine:

Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda,

Unani, Siddha, Homeopathy and Chinese systems of medicine.

Introduction to secondary metabolites:

Definition, classification, properties and test for identification of Alkaloids, Glycosides,

Flavonoids, Tannins, Volatile oil and Resins.

Unit V

Study of biological source, chemical nature and uses of drugs of natural origin containing

following drugs

Plant Products:

Fibers – Cotton, Jute, Hemp

Hallucinogens, Teratogens, Natural allergens

Primary metabolites:

General introduction, detailed study with respect to chemistry, sources, preparation, evaluation, preservation, storage, therapeutic used and commercial utility as Pharmaceutical

Aids and/or Medicines for the following

Primary metabolites: Carbohydrates: Acacia, Agar, Tragacanth, Honey, Proteins and Enzymes: Gelatin, casein, proteolytic enzymes (Papain, bromelain, serratiopeptidase, urokinase, streptokinase, pepsin).

Lipids(Waxes, fats, fixed oils): Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax

Marine Drugs:

Novel medicinal agents from marine sources

1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv)Gelatin (v) starch (vi) Honey (vii) Castor oil

2. Determination of stomatal number and index

3. Determination of vein islet number, vein islet termination and paliside ratio.

4. Determination of size of starch grains, calcium oxalate crystals by eye piece micrometer

5. Determination of Fiber length and width

6. Determination of number of starch grains by Lycopodium spore method

7. Determination of Ash value

8. Determination of Extractive values of crude drugs

9. Determination of moisture content of crude drugs

10. Determination of swelling index and foamingB. Pharmacy 2nd Year Subjects & Syllabus PDF B Pharm Second Year 3 + 4 Semester PDF DOWNLOAD

B. Pharmacy 2nd Year Subjects & Syllabus PDF B Pharm Second Year 3 + 4 Semester PDF DOWNLOAD
Scenario of Pharmacy abroad

In some countries, B. Pharm degree has been superseded by the Doctor of Pharmacy (Pharm. D) and Master of Pharmacy (M. Pharm) degrees. In the United Kingdom B. Pharm is replaced by M. Pharm long back. Pharmacy is taught in University of Helsinki and University of Eastern Finland. M. Pharm is a must in order to be a druggist. In the Republic of Ireland, M. Pharm (Hons) degrees are offered by Trinity College, Dublin, University College Cork, Royal College of Surgeons in Ireland, Dublin. However, in Northern Ireland (which is part of the United Kingdom) M. Pharm degrees (as opposed to BSc or B. Pharm degrees) are offered at Queen’s University Belfast as in the rest of the UK. In Pakistan, Pharm. D is the only Basic Pharmacy Degree (5 years program) awarded by universities approved by Pharmacy Council of Pakistan.

B. Pharmacy 1st Year Subjects & Syllabus – PDF – B. Pharm First Year Semester {Sem 1 + 2}

July 26, 2020March 27, 2018 by Renee

B. Pharmacy 1^st Year Subjects and Syllabus:

B. Pharm(a) also called Bachelor in Pharmacy, is an undergraduate academic degree in the medical field of Pharmacy. In the United States, at Washington State University this degree was granted as the baccalaureate pharmacy degree only, where it has now been superseded by the Pharm. D degree. In India, Pharmacy Council of India (PCI) is responsible to provide Pharmacy graduate level education all over the universities. Hence, it is a statutory body that is regulated by the provisions of the Pharmacy Act, 1948, passed by the Indian Parliament. One is eligible to opt for this course after successfully completing Standard Twelve in science stream with Physics, Chemistry, Maths or Biology as combination subjects. Students of Pharmacy are expected to they perform various experiments preparing new drugs for various diseases as practical knowledge along with the theory part. You are always free to discuss about your queries in the comment section below. Here we are going to know about the first year curriculum.

Govt Banned drugs 2018: Latest Govt News on sale of Banned drugs

329 FDC Banned Drugs List in India – PDF Full Download – 2018 – Latest News

Regulations:

The total duration of the course- 4 years. Typically the course spread out over 6-8 semesters. Each year consists of 2 semesters ideally. Each semester shall consist of minimum 100 working days.
Eligibility- 10+2 passed with Science stream subjects (PCB or PCM) from a recognized board with English as one of the subjects and at least 50% marks is the minimum educational qualification. In some states, it is also compulsory to follow their own additional entrance tests.
Entrance Examination: BHU B. Pharma Entrance Examination, GPAT- Graduate Pharmacy Aptitude Test, MHT-CET Maharashtra Common Entrance Test, GCET-Goa Common Entrance Test etc.

Subjects for B Pharm 1st year (Semester 1)

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
HUMAN ANATOMY AND PHYSIOLOGY-I	45	100	4/week	50
PHARMACEUTICAL ANALYSIS	45	100	4/week	50
PHARMACEUTICS- I	45	100	3/week	50
PHARMACEUTICAL INORGANIC CHEMISTRY	45	100	4/week	50
COMMUNICATION SKILLS*	30	50	2/week	25
REMEDIAL BIOLOGY/ REMEDIAL MATHEMATICS(Only theory)	30	50	30	25

Total marks	675/725 ^$/750^#

^#Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB) course.

^$Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics (RM) course.

* Non University Examination (NUE)

Mobile Apps for Pharmacy Students

After B Pharm???? What to do After B Pharmacy????

Syllabus for 1st Semester

Subjects	Syllabus
Subjects	Theory	Practical
HUMAN ANATOMY AND PHYSIOLOGY-I	Unit I(Introduction to human body, Cellular level of organization, Tissue level of organization); Unit II(Integumentary system, Skeletal system, Joints); Unit III(Body fluids and blood, Lymphatic system); Unit IV(Peripheral nervous system, Peripheral nervous system); Unit V (Cardiovascular system)	1. Study of compound microscope. 2. Microscopic study of epithelial and connective tissue 3. Microscopic study of muscular and nervous tissue 4. Identification of axial bones 5. Identification of appendicular bones 6. Introduction to hemocytometry. 7. Enumeration of white blood cell (WBC) count 8. Enumeration of total red blood corpuscles (RBC) counts 9. Determination of bleeding time 10. Determination of clotting time 11. Estimation of hemoglobin content 12. Determination of blood group. 13. Determination of erythrocyte sedimentation rate (ESR). 14. Determination of heart rate and pulse rate. 15. Recording of blood pressure.
PHARMACEUTICAL ANALYSIS	Unit I(Pharmaceutical analysis, Errors, Pharmacopoeia); Unit II(Acid base titration, Non aqueous titration); Unit III(Precipitation titration, Complexometric titration, Gravimetry, Basic Principles,methods and application of diazotisation titration); Unit IV(Redox titrations); Unit V(Electrochemical methods of analysis- Conductometry, Potentiometry, Polarography)	Limit Tests- (1) Chloride (2) Sulphate (3) Iron (4) Arsenic; Preparation and standardization of -(1) Sodium hydroxide (2) Sulphuric acid (3) Sodium thiosulfate (4) Potassium permanganate (5) Ceric ammonium sulphate; Assay of the following compounds along with Standardization of Titrant- (1) Ammonium chloride by acid base titration (2) Ferrous sulphate by Cerimetry (3) Copper sulphate by Iodometry (4) Calcium gluconate by complexometry (5) Hydrogen peroxide by Permanganometry (6) Sodium benzoate by non-aqueous titration (7) Sodium Chloride by precipitation titration; Determination of Normality by electro-analytical methods – (1) Conductometric titration of strong acid against strong base (2) Conductometric titration of strong acid and weak acid against strong base (3) Potentiometric titration of strong acid against strong base
PHARMACEUTICS- I	Unit I(Historical background and development of profession of pharmacy, Prescription, Dosage forms, Posology); Unit II(Pharmaceutical calculations, Powders, Liquid dosage forms); Unit III(Monophasic liquids, Biphasic liquids Suspensions, Emulsions); Unit IV(Suppositories, Pharmaceutical incompatibilities); Unit V-Semisolid dosage forms	1. Syrups a) Syrup IP’66 b) Compound syrup of Ferrous Phosphate BPC’68 2. Elixirs a) Piperazine citrate elixir b) Paracetamol pediatric elixir 3.Linctus a) Terpin Hydrate Linctus IP’66 4. Solutions b) Iodine Throat Paint (Mandles Paint) a) Strong solution of ammonium acetate b) Cresol with soap solution c) Lugol’s solution 5. Suspensions a) Calamine lotion b) Magnesium Hydroxide mixture c) Aluminimum Hydroxide gel 6. Emulsions a) Turpentine Liniment b) Liquid paraffin emulsion 7. Powders and Granules a) ORS powder (WHO) b) Effervescent granules c)Dusting powder d)Divded powders 8. Suppositories a) Glycero gelatin suppository b) Coca butter suppository c) Zinc Oxide suppository 8. Semisolids a) Sulphur ointment b) Non staining-iodine ointment with methyl salicylate c) Carbopal gel 9. Gargles and Mouthwashes a) Iodine gargle b) Chlorhexidine mouthwash
PHARMACEUTICAL INORGANIC CHEMISTRY	Unit I(Impurities in pharmaceutical substances, General methods of preparation of compounds); Unit II(Acids, Bases and Buffers, Major extra and intracellular electrolytes, Dental products); Unit III(Gastrointestinal agents, Acidifiers, Antacid, Cathartics, Antimicrobials); Unit IV(Miscellaneous compounds, Expectorants, Emetics, Haematinics, Poison and Antidote, Astringents); Unit V- Radiopharmaceuticals	1.Limit tests for following ions(Chlorides and Sulphates Modified limit test for Chlorides and Sulphates Limit test for Iron Limit test for Heavy metals Limit test for Lead Limit test for Arsenic) 2. Identification test Magnesium hydroxide Ferrous sulphate Sodium bicarbonate Calcium gluconate Copper sulphate 3.Test for purity Swelling power of Bentonite Neutralizing capacity of aluminum hydroxide gel Determination of potassium iodate and iodine in potassium Iodide 4.Preparation of inorganic pharmaceuticals Boric acid Potash alum Ferrous sulphate
COMMUNICATION SKILLS	Unit I(Communication Skills, Barriers to communication, Perspectives in Communication); Unit II(Elements of Communication, Communication Styles); Unit III(Basic Listening Skills, Effective Written Communication, Writing Effectively); Unit IV(Interview Skills, Giving Presentations); Unit V- Group Discussion	Basic communications covering the following topics -Meeting People Asking Questions Making Friends What did you do? Do’s and Don’ts; Pronunciations covering the following topics- Pronunciation (Consonant Sounds) Pronunciation and Nouns Pronunciation (Vowel Sounds); Advanced Learning Listening Comprehension / Direct and Indirect Speech Figures of Speech Effective Communication Writing Skills Effective Writing Interview Handling Skills E-Mail etiquette Presentation Skills
REMEDIALBIOLOGY	Unit I(Living world, Morphology of Flowering plants); Unit II(Body fluids and circulation, Digestion and Absorption, Breathing and respiration); Unit III(Excretory products and their elimination, Neural control and coordination, Chemical coordination and regulation, Human reproduction); Unit IV(Plants and mineral nutrition, Photosynthesis); Unit V(Plant respiration, Plant growth and development, Cell – The unit of life, Tissues	1. Introduction to experiments in biology a) Study of Microscope b) Section cutting techniques c) Mounting and staining d) Permanent slide preparation 2. Study of cell and its inclusions 3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications 4. Detailed study of frog by using computer models 5. Microscopic study and identification of tissues pertinent to Stem, Root Leaf, seed, fruit and flower 6. Identification of bones 7. Determination of blood group 8. Determination of blood pressure 9. Determination of tidal volume
REMEDIAL MATHEMATICS	Unit I(Partial fraction, Logarithms, Function, Limits and continuity); Unit II(Matrices and Determinant); Unit III(Calculus –Differentiation); Unit IV(Analytical Geometry- Introduction, Straight Line, Integration); Unit V(Differential Equations-Application in solving Pharmacokinetic equations, Laplace Transform- Application in solving Chemical kinetics and Pharmacokinetics equations)

B Pharmacy first year Subjects for Semester 2

Subjects	Theory		Practical
Subjects	Hours	Marks	Hours	Marks
HUMAN ANATOMY AND PHYSIOLOGY-II	45	100	4/week	50
PHARMACEUTICAL ORGANIC CHEMISTRY-I	45	100	4/week	50
BIOCHEMISTRY	45	100	4/week	50
PATHOPHYSIOLOGY	45	100	–	–
COMPUTER APPLICATIONS IN PHARMACY*	30	75	–	25
ENVIRONMENTAL SCIENCES*	30	75	–	–

Total marks	725

* The subject experts at college level shall conduct examinations

B Pharma First year Syllabus for Semester 2

Subjects

Syllabus

Theory

Practical

HUMAN ANATOMY AND PHYSIOLOGY-II

Unit I- Nervous system (Organization of nervous system, neuron, neuroglia, classification and properties of nerve fibre, electrophysiology, action potential, nerve impulse, receptors, synapse, neurotransmitters. Central nervous system: Meninges, ventricles of brain and cerebrospinal fluid, structure and functions of brain (cerebrum, brain stem, cerebellum), spinal cord (gross structure, functions of afferent and efferent nerve tracts, reflex activity) ); Unit II- Digestive system (Anatomy of GI Tract with special reference to anatomy and functions of stomach, Acid production in the stomach, regulation of acid production through parasympathetic nervous system, pepsin role in protein digestion) small intestine 54 and large intestine, anatomy and functions of salivary glands, pancreas and liver, movements of GIT, digestion and absorption of nutrients and disorders of GIT. Energetics-Formation and role of ATP, Creatinine Phosphate and BMR) ;Unit III- Respiratory system (Anatomy of respiratory system with special reference to anatomy of lungs, mechanism of respiration, regulation of respiration Lung Volumes and capacities transport of respiratory gases, artificial respiration, and resuscitation methods), Urinary system (Anatomy of urinary tract with special reference to anatomy of kidney and nephrons, functions of kidney and urinary tract, physiology of urine formation, micturition reflex and role of kidneys in acid base balance, role of RAS in kidney and disorders of kidney); Unit IV- Endocrine system (Classification of hormones, mechanism of hormone action, structure and functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreas, pineal gland, thymus and their disorders.); Unit V- Reproductive system (Anatomy of male and female reproductive system, Functions of male and female reproductive system, sex hormones, physiology of menstruation, fertilization, spermatogenesis, oogenesis, pregnancy and parturition), Introduction to genetics Chromosomes, genes and DNA, protein synthesis, genetic pattern of inheritance

1. To study the integumentary and special senses using specimen, models, etc., 2. To study the nervous system using specimen, models, etc., 3. To study the endocrine system using specimen, models, etc 4. To demonstrate the general neurological examination 5. To demonstrate the function of olfactory nerve 6. To examine the different types of taste. 7. To demonstrate the visual acuity 8. To demonstrate the reflex activity 9. Recording of body temperature 10. To demonstrate positive and negative feedback mechanism. 11. Determination of tidal volume and vital capacity. 12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive systems with the help of models, charts and specimens. 13. Recording of basal mass index. 14. Study of family planning devices and pregnancy diagnosis test. 15. Demonstration of total blood count by cell analyser 16. Permanent slides of vital organs and gonads

PHARMACEUTICAL ORGANIC CHEMISTRY –I

Unit I- Classification, nomenclature and isomerism, Classification of Organic Compounds Common and IUPAC systems of nomenclature of organic compounds (up to 10 Carbons open chain and carbocyclic compounds) Structural isomerisms in organic compounds); Unit II- Alkanes*, Alkenes* and Conjugated dienes* (SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins. Stabilities of alkenes, SP2 hybridization in alkenes E1 and E2 reactions – kinetics, order of reactivity of alkyl halides, rearrangement of carbocations, Saytzeffs orientation and evidences. E1 verses E2 reactions, Factors affecting E1 and E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes, Markownikoff’s orientation, free radical addition reactions of alkenes, Anti Markownikoff’s orientation. Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition reactions of conjugated dienes, allylic rearrangement); Unit III- Alkyl halides* (SN1 and SN2 reactions – kinetics, order of reactivity of alkyl halides, stereochemistry and rearrangement of carbocations. SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions, Structure and uses of ethylchloride, Chloroform, trichloroethylene, tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform), Alcohols*( Qualitative tests, Structure and uses of Ethyl alcohol, Methyl alcohol, chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol, Propylene glycol); Unit IV- Carbonyl compounds* (Aldehydes and ketones) Nucleophilic addition, Electromeric effect, aldol condensation, Crossed Aldol condensation, Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation, Perkin condensation, qualitative tests, Structure and uses of Formaldehyde, Paraldehyde, Acetone, Chloral hydrate, Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde); Unit V- Carboxylic acids* (Acidity of carboxylic acids, effect of substituents on acidity, inductive effect and qualitative tests for carboxylic acids ,amide and ester Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid, Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl benzoate, Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid), Aliphatic amines* – Basicity, effect of substituent on Basicity. Qualitative test, Structure and uses of Ethanolamine, Ethylenediamine, Amphetamine)

I. Systematic qualitative analysis of unknown organic compounds like

1. Preliminary test: Color, odour, aliphatic/aromatic compounds, saturation and unsaturation, etc. 2. Detection of elements like Nitrogen, Sulphur and Halogen by Lassaigne’s test 3. Solubility test 4. Functional group test like Phenols, Amides/ Urea, Carbohydrates, Amines, Carboxylic acids, Aldehydes and Ketones, Alcohols, Esters, Aromatic and Halogenated Hydrocarbons, Nitro compounds and Anilides. 5. Melting point/Boiling point of organic compounds 6. Identification of the unknown compound from the literature using melting point/ boiling point. 7. Preparation of the derivatives and confirmation of the unknown compound by melting point/ boiling point. 8. Minimum 5 unknown organic compounds to be analysed systematically;

II- Preparation of suitable solid derivatives from organic compounds;

III. Construction of molecular models

BIOCHEMISTRY

Unit I– Biomolecules (Introduction, classification, chemical nature and biological role of carbohydrate, lipids, nucleic acids, amino acids and proteins), Bioenergetics (Concept of free energy, endergonic and exergonic reaction, Relationship between free energy, enthalpy and entropy; Redox potential. Energy rich compounds; classification; biological significances of ATP and cyclic AMP) ; Unit II- Carbohydrate metabolism(Glycolysis – Pathway, energetics and significance,Citric acid cycle- Pathway, energetics and significance, HMP shunt and its significance, Glucose-6-Phosphate dehydrogenase (G6PD) deficiency, Glycogen metabolism Pathways and glycogen storage diseases (GSD), Gluconeogenesis- Pathway and its significance, Hormonal regulation of blood glucose level and Diabetes mellitus), Biological oxidation(Electron transport chain (ETC) and its mechanism. Oxidative phosphorylation & its mechanism and substrate phosphorylation, Inhibitors ETC and oxidative phosphorylation/Uncouplers.); Unit III –Lipid metabolism(β-Oxidation of saturated fatty acid (Palmitic acid), Formation and utilization of ketone bodies, ketoacidosis

De novo synthesis of fatty acids (Palmitic acid), Biological significance of cholesterol and conversion of cholesterol into

bile acids, steroid hormone and vitamin D,Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty liver and obesity.) Amino acid metabolism

(General reactions of amino acid metabolism: Transamination,

deamination & decarboxylation, urea cycle and its disorders,

Catabolism of phenylalanine and tyrosine and their metabolic disorders(Phenyketonuria, Albinism, alkeptonuria, tyrosinemia), Synthesis and significance of biological substances; 5-HT, melatonin,

dopamine, noradrenaline, adrenaline, Catabolism of heme; hyperbilirubinemia and jaundi); Unit IV- Nucleic acid metabolism and genetic information transfer

(Biosynthesis of purine and pyrimidine nucleotides,

Pharmacology Text Books Lists

Catabolism of purine nucleotides and Hyperuricemia and Gout disease, Organization of mammalian genome,

Structure of DNA and RNA and their functions, DNA replication (semi conservative model),

Transcription or RNA synthesis

Genetic code, Translation or Protein synthesis and inhibitors); Unit V- Enzymes

(Introduction, properties, nomenclature and IUB classification of enzymes,

Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)

Enzyme inhibitors with examples,

Regulation of enzymes: enzyme induction and repression, allosteric

enzymes regulation, Therapeutic and diagnostic applications of enzymes and isoenzymes, Coenzymes –Structure and biochemical functions)

1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose,Sucrose and starch)

2. Identification tests for Proteins (albumin and Casein)

3. Quantitative analysis of reducing sugars (DNSA method) and Proteins (Biuret method)

4. Qualitative analysis of urine for abnormal constituents

5. Determination of blood creatinine

6. Determination of blood sugar

7. Determination of serum total cholesterol

8. Preparation of buffer solution and measurement of pH

9. Study of enzymatic hydrolysis of starch

10. Determination of Salivary amylase activity

11. Study the effect of Temperature on Salivary amylase activity

12. Study the effect of substrate concentration on salivary amylase activity.

PATHOPHYSIOLOGY

Unit I – Basic principles of Cell injury and Adaptation:

(Introduction, definitions, Homeostasis, Components and Types of Feedback systems,

Causes of cellular injury, Pathogenesis (Cell membrane damage, Mitochondrial damage,

Ribosome damage, Nuclear damage),Morphology of cell injury – Adaptive changes

(Atrophy, Hypertrophy, hyperplasia, Metaplasia, Dysplasia),Cell swelling, Intra cellular accumulation, Calcification, Enzyme leakage and Cell Death Acidosis & Alkalosis, Electrolyte imbalance), Basic mechanism involved in the process of inflammation and repair:

(Introduction, Clinical signs of inflammation, Different types of Inflammation, Mechanism

of Inflammation – Alteration in vascular permeability and blood flow, migration of

WBC’s, Mediators of inflammation, Basic principles of wound healing in the

skin, Pathophysiology of Atherosclerosis); Unit II– Cardiovascular System:

(Hypertension, congestive heart failure, ischemic heart disease (angina, myocardial infarction, atherosclerosis and arteriosclerosis), Respiratory system: (Asthma, Chronic obstructive airways diseases.), Renal system: (Acute and chronic renal failure.)

Unit III- Haematological Diseases: (Iron deficiency, megaloblastic anemia (Vit B12 and folic acid), sickle cell anemia, thalasemia, hereditary acquired anemia, haemophilia), Endocrine system: (Diabetes, thyroid diseases, disorders of sex hormones.), Nervous system: (Epilepsy, Parkinson’s disease, stroke, psychiatric disorders:

Depression, schizophrenia and Alzheimer’s disease.), Gastrointestinal system: (Peptic Ulcer),

Unit IV– Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F) alcoholic liver

Disease, Disease of bones and joints: (Rheumatoid arthritis, osteoporosis and gout), Principles of cancer: (classification, etiology and pathogenesis of cancer), Diseases of bones and joints: (Rheumatoid Arthritis, Osteoporosis, Gout), Principles of Cancer: (Classification, etiology and pathogenesis of Cancer)

Unit V- Infectious diseases: (Meningitis, Typhoid, Leprosy, Tuberculosis, Urinary tract infections), Sexually transmitted diseases: (AIDS, Syphilis, Gonorrhea)

When to Write a Pharmacy Progress Note

COMPUTER APPLICATIONS IN PHARMACY

Unit IV- Number system: (Binary number system, Decimal number system, Octal

number system, Hexadecimal number systems, conversion decimal to binary, binary to decimal, octal to binary etc, binary addition, binary

subtraction – One’s complement ,Two’s complement method, binary multiplication, binary division.), Concept of Information Systems and Software : (Information gathering, requirement and feasibility analysis, data flow diagrams, process specifications, input/output design, process life cycle, planning and managing the project.); Unit II- Web technologies: (Introduction to HTML, XML,CSS and

Programming languages, introduction to web servers and Server Products, Introduction to databases, MYSQL, MS ACCESS, Pharmacy Drug database.); Unit III- Application of computers in Pharmacy (Drug information storage and

retrieval, Pharmacokinetics, Mathematical model in Drug design, Hospital and Clinical Pharmacy, Electronic Prescribing and discharge (EP) systems, barcode medicine identification and automated dispensing of drugs, mobile technology and adherence monitoring, Diagnostic System, Lab-diagnostic System, Patient Monitoring System, Pharma Information System); Unit IV- Bioinformatics: (Introduction, Objective of Bioinformatics, Bioinformatics Databases, Concept of Bioinformatics, Impact of Bioinformatics in Vaccine Discovery)

Unit-V Computers as data analysis in Preclinical development:

(Chromatographic dada analysis(CDS), Laboratory Information management

System (LIMS) and Text Information Management System(TIMS))

1. Design a questionnaire using a word processing package to gather information about a particular disease.

2. Create a HTML web page to show personal information.

3. Retrieve the information of a drug and its adverse effects using online tools

4 Creating mailing labels Using Label Wizard , generating label in MS WORD

5. Create a database in MS Access to store the patient information with the required fields Using access

6. Design a form in MS Access to view, add, delete and modify the patient record in the database

7. Generating report and printing the report from patient database

8. Creating invoice table using – MS Access

9. Drug information storage and retrieval using MS Access

10. Creating and working with queries in MS Access

11. Exporting Tables, Queries, Forms and Reports to web pages

12. Exporting Tables, Queries, Forms and Reports to XML pages

ENVIRONMENTAL SCIENCES

Unit-I:The Multidisciplinary nature of environmental studies

Natural Resources (Renewable and non-renewable resources: Natural resources and associated problems a) Forest resources; b) Water resources; c) Mineral resources; d) Food resources; e) Energy resources; f) Land resources: Role of an individual inconservation of natural resources.); Unit II: Ecosystems

§ Concept of an ecosystem.

§ Structure and function of an ecosystem.

§ Introduction, types, characteristic features, structure and function of

the ecosystems: Forest ecosystem; Grassland ecosystem; Desert

ecosystem; Aquatic ecosystems (ponds, streams, lakes, rivers, oceans,

estuaries); Unit- III:

Environmental Pollution: Air pollution; Water pollution; Soil pollution.

B pharmacy first year syllabus Subjects semister wise PDF

Information related to Bachelor in Pharmacy degree

The fees of B. Pharmacy course is near about 1.5 lacs per semester. B.Pharm students who excel in academics can avail the scholarship in India as well as abroad. There are some scholarship programmes conducted by some universities based on the few criteria. One of them is called as Apex Life Scholarship and it is for Higher Studies in India/Abroad. The amount in India varies between Rs. 500/- to Rs. 3500/- (monthly) whereas Rs. 1 lac to Rs. 5 lacs for abroad studies. Starting from the qualification of H.Sc, SSC, Undergraduates, Postgraduates and students of Professional Courses can apply for the same.

What to do After B. Pharmacy?

To name some private organisations offering scholarships to students for education include Mahalaxmi Education Trust, Bombay, C. Mahindra Education Trust, Sahu Jain Trust, Birla Education Trust, J.N. Tata Endowment and Aga Khan Education Service (India). Also one can consider the option of taking a loan from banks offering education loans.

Approach to Process Validation:

Validation Protocol:

PROCESS VALIDATION PROTOCOL -Pharmaceutical (Autoclave)

1. PRE-EXECUTION APPROVAL

3.0 INSTRUCTIONS

4. RESPONSIBILITIES

7.0 Equipment Identification

DOCUMENTATION

GLOSSARY OF TERMS

Pharmaceutical-contract-manufacturing organization setup

CMOs offer:

Setup strategy

Notes

Quality Control Executive Interview Questions & Answers

Quality Control Executive Interview Questions & Answers QA + QC PDF – Pharma Company Job Interview

What is Friability Testing?

PROCEDURE FOR OPERATION AND CLEANING FRIABILATOR

CLEANING FRIABILATOR

:

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator

CORRECT OPERATION:

Conclusion

Precautions:

Top 5 Free Apps for Pharmacy Students

Rx Shortages

Lexicomp

Medscape

Pocket Pharmacist

iPharmacy

Each step in the manufacturing process follows these basic principles:-

GMP Implementation

B pharm Subjects for 3rd year (Semester 5)

B pharmacy Syllabus for Semester 5

Subject: INDUSTRIAL PHARMACY

B Pharm Subjects for Semester 6

B pharmacy Syllabus for Semester 6

B Pharm Subject: PHARMACOLOGY-III

B. Pharmacy Subjects for 2nd year (Semester 3)

Subject: PHYSICAL PHARMACEUTICS-I

Subject: PHARMACEUTICAL ENGINEERING

B. Pharmacy Subjects for Semester 4

B. Pharmacy Second Year Syllabus for Semester 4

Subject: PHARMACEUTICAL ORGANIC CHEMISTRY –III

Subject: MEDICINAL CHEMISTRY – I

Subject: PHYSICAL PHARMACEUTICS-II

B. Pharmacy 2nd Year Subjects & Syllabus PDF B Pharm Second Year 3 + 4 Semester PDF DOWNLOAD Scenario of Pharmacy abroad

Subjects for B Pharm 1st year (Semester 1)

B Pharmacy first year Subjects for Semester 2

Information related to Bachelor in Pharmacy degree

B. Pharmacy 2nd Year Subjects & Syllabus PDF B Pharm Second Year 3 + 4 Semester PDF DOWNLOAD
Scenario of Pharmacy abroad