Pharma QA Job Interview Guide |+| Quality Assurance Interview Questions – Pharmaceutical Industry

Pharma QA Job Interview Guide Quality Assurance Interview Questions - Pharmaceutical Industry

Pharma QA Interview Question And Answer are here presented for you to help you to crack Quality Assurance Interview in Pharmaceutical manufacturing companies. Definition Of Quality Assurance along with its use In Pharma Industry are listed here below.

Quality Assurance Pharma Interview Questions – Part 1

Sample QA Interview Question:  Define quality assurance
Ans) QA is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning and documenting the procedures to assure the quality of the product.

Sample QA Interview Question: What needs to be checked during inprocess QA checks?
A.
a.) Environmental Monitoring
b.) Measured values obtained from the process equipment (ex:temperature,RPM etc.)
c.) Measured values obtained from persons (ex:timmings,entries etc.)
d.) Process attributes (Ex:weight,hardness,friability etc.)

Sample QA Interview Question: What precautions shall be taken while collecting inprocess samples ?
A. While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.

Sample QA Interview Question: In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or service corridors?
A. In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.

Sample QA Interview Question: If sticking observed during tablet compression what may the probable reason for the same?
A.
1.If the granules are not dried properly sticking can
occur.
2.Too little or improper lubrication can also leads to
sticking.
3.Sticking can occur because of too much binder or
hygroscopic granular.

Sample QA Interview Question: What checks shall be carried out, while calibrating DT apparatus?
A. While calibrating DT apparatus, following checks shall be performed.
1.) Number of strokes per minute (Limit:29-32 cycles/min)
2.) Temperature by probe & standard thermometer
(Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53 -57mm)

Explain the difference between QC and QA?

Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.

QA Interview Question: . Expand cGMP and what is the difference between GMP and cGMP?

Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure proper design , manufacturing and control of manufacturing processes and services.

GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug administration to make sure that a product is manufactured with safety and quality. c in cGMP means current. It refers to recent and advance updates to these standard guidelines. cGMP is up to date standard reference guidelines.

Pharma QA Job Interview Guide |+| Quality Assurance Interview Questions – Pharmaceutical Industry

Pharma QA Job Interview Guide Quality Assurance Interview Questions - Pharmaceutical Industry

Pharma QA Job Interview Q&A:  Tell me any five countries with their regulatory authorities?
Ans) India – Central Drugs Standard Control Organisation (CDSCO)

USA – United States Food and Drug Administation (USFDA)

UK – Medicines and Healthcare products Regulatory Agency (MHRA)

Japan- Ministry of Health Labour and Welfare (MHLW)

Australia- Therapeutics Goods Administration (TGA)

Sample QA Interview Question: What is In process checks?
A. In process checks are checks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.

Sample QA Interview Question: What is the difference between disintegration and dissolution?
A. Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).

Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent.

In other word disintegration is a subset of dissolution.

Sample QA Interview Question: Why do we calibrate a qualified equipment/instrument on definite intervals?
A. An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.

Pharma Quality Assurance Interview Q&A: What is room temperature?

Ans) 25 degree centigrade

Pharma Quality Assurance Interview Q&A:  What is the Ultraviolet(UV) and visible spectroscopy range?

Ans) UV spectroscopy range 200-400 nm, Visible spectroscopy range 400 nm to 800nm.

Pharma Quality Assurance Interview Q&A: What is the use of UV Spectroscopy?

Ans) Spectroscopy used for detecting the functional groups, impurities. Qualitative and quantitative analysis can be done.

Pharma QA Job Interview Guide Part 2

Sample QA Interview Question:  What is the difference between qualitative and quantitative analysis?

Ans) Qualitative analysis involves identification of the compound or chemical based on their chemical(absorption, emission )or physical properties(e.g Melting point, boiling point).

Quantitative analysis involves estimation or determination of concentration or amount of the chemical compounds or components.

Q5) Explain the principle of Ultraviolet spectroscopy?

Ans) UV spectroscopy uses light in the UV part of electromagnetic spectrum. UV absorption spectra arises in which molecule or atoms outer electrons absorb energy, undergoes transition from lower energy level to higher energy level. For each molecule, absorbance at wavelength is specific.

Q6) Explain about Beer Lamberts law?

Ans) It states that the intensity of monochromatic light absorbed by a substance dissolved in a fully transmitting solvent is directly proportional to the substance concentration and the path length of the light through the solution.

Q7) Explain the Infrared spectroscopy principle?

Ans) When a molecule absorbs the Infrared radiation, it vibrates and gives rise to packed Infrared(IR) absorption spectrum. This IR spectrum is specific for every different molecule absorbing the IR radiation, useful for its identification.

Q8) What is the body temperature?

Ans) 37 oCelsius or 98.6 oF

v Define pH? What is the pH of blood?
Ans) pH -Negative logarithm of hydrogen ion concentration. Blood pH-7.35 to 7.45.

Q10) Expand LCMS, HPLC,UPLC, TLC and GC?

Ans) LCMS- Liquid Chromatography

HPLC- High Performance Liquid Chromatography,

UPLC- Ultra High Performance Liquid Chomatography,

TLC- Thin Layer Chomatography,

GC- Gas Chromatography.

qc pharma interview questions for freshers

Q11) What is the HPLC principle?

Ans) It is a technique used for separating the mixture of components into individual components based on adsorption, partition, ion exchange and size exclusion principles. Stationary phase and mobile phase used in it. HPLC used for identification, quantification and purification of components form a mixture.

Q12) Explain HPLC instrumentation?

Ans) It involves solvent system, pump, Sample injector, HPLC columns, Detectors and Recorder. Firstly, solvent(mobile phase) is degassed for eliminating the bubbles. It is passed through the pump with a uniform pressure. The liquid sample is injected into the mobile phase flow stream. It passes through the stationary phase identified by the detectors and recorded.

Q13) In reverse phase HPLC, which type of stationary phase is used and give example?

Ans) Non polar stationary phase used

Ex: Silica gel C-18

Q14) What are the detectors used in HPLC?

Ans) UV detector, IR detector, Fluorescence detector, Mass spectroscopy, LC MS etc.

Q15) How to calculate Retention factor in paper chromatography?
Ans) Rf = Distance travelled by solute/ Distance travelled by solvent.

Q16) Define molarity?

Ans) Number of moles of solute per litre solution. Denoted with “M”

Quality Assurance Pharma Interview Questions – Part 2

Q17) Define Molality?

Ans) Number of moles of solute per kilogram solvent. Denoted with “m”

Q18) Define Normality?

Ans) Number of Number of moles equivalent per litre solution.

 

Q19) Molecular weight of oxygen?

Ans) 16

Difference between humidity and relative humidity?

Ans) Humidity – Measure of amount of water vapour present in the atmosphere.

Relative humidity- Water vapour amount exists in air expressed as a percentage of the amount needed for saturation at the same temperature.

Sample QA Interview Question: Why do we consider three consecutive runs/batches for process validation? Why not two or four?
A. The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
· First batch quality is accidental (co-incidental),
· Second batch quality is regular (accidental),
· Third batch quality is validation(conformation).
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.

Sample QA Interview Question: Explain about revalidation criteria of AHU system?
A. AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be revalidated in following cases also.
· When basic design of AHU is changed,
· When clean room volume is changed,
· When new equipment is installed
· When a construction is carried out, that calls for reconstruction of AHU system.

Sample QA Interview Question: What needs to be checked during AHU validation?
A. During AHU validation, following tests shall be carried out
· Filter efficiency test,
· Air velocity & number of air changes,
· Air flow pattern (visualization)
· Differential pressure, temperature and RH
· Static condition area qualification
· Dynamic condition qualification
· Non-viable count
· Microbial monitoring
· Area recovery and power failure study.

Sample QA Interview Question: Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / widthwise?
A. Position of oblong tablets should be length wise because the probability of breakage is more in this position.

Sample QA Interview Question: Explain in detail about qualification of pharmaceutical water system?
A. Qualification of pharmaceutical water system involves three phases
· Phase -1
· Phase -2
· Phase -3
Phase -1
A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach.
· Under take chemical & microbiological testing in accordance with a defined plan.
· Sample incoming feed water daily to verify its quality.
· Sample each step of purification process daily.
· Sample each point of use daily.
· Develop appropriate operating ranges.
· Demonstrate production and delivery of product water of required quantity and quality.
· Use and refine the SOP’s for operation,maintenance,sanitization and trouble shooting.
· Verify provisional alert and action levels.
· Develop and refine test failure procedure.

Phase -2
A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase.
Approach should also
· Demonstrate consistent operation within established ranges.
· Demonstrate consistent production & delivery of water of required quality and quantity.

Phase – 3
Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.

Objectives & Features of Phase -3
· Demonstrate extensive reliable performance.
· Ensure that seasonal variations are evaluated.
· The sample locations, sampling frequencies and test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase – 2.

Sample QA Interview Question: What are the recommended environmental monitoring limits for microbial contamination?

Sample QA Interview Question: What is the difference between calibration and Validation?
A. Calibration is a demonstration that, a particular
Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.

Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.

In calibration performance of an instrument or device is comparing against a reference standard. But in validation such reference standard is not using.

Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).

Sample QA Interview Question: Briefly explain about ICH climatic zones for stability testing & long term storage conditions?
A.ICH STABILITY ZONES
Zone
Type of Climate
Zone I
Temperate zone
Zone II
Mediterranean/subtropical zone
Zone III
Hot dry zone
Zone IVa
Hot humid/tropical zone
Zone IVb
ASEAN testing conditions hot/higher humidity

Long term Storage condition
Climatic Zone
Temperature
Humidity
Minimum Duration
Zone I
21ºC ± 2ºC
45% rH ± 5% rH
12 Months
Zone II
25ºC ± 2ºC
60% rH ± 5% rH
12 Months
Zone III
30ºC ± 2ºC
35% rH ± 5% rH
12 Months
Zone IV
30ºC ± 2ºC
65% rH ± 5% rH
12 Months
Zone IVb
30ºC ± 2ºC
75% rH ± 5% rH
12 Months
Refrigerated
5ºC ± 3ºC
No Humidity
12 Months
Frozen
-15ºC ± 5ºC
No Humidity
12 Months

Sample QA Interview Question: What is bracketing & matrixing in stability testing?
A.Both Matrixing & Bracketing’s are reduced stability testing designs
Bracketing
The design of a stability schedule, such that only samples of extremes of certain design factors (ex:strength,package size) are tested at all time points as in full design.The designs assumes that the stability of any intermediate level is represented by the stability of extremes tested.
Matrixing
The design of a stability schedule, such that a selected subset of possible samples for all factor combinations is tested at a specified time point.At a subsequent time point another subset of samples for all factor combination is tested.The design assumes that the stability of each subset samples tested represents the stability of all samples at a given time point.
There for a given time point other than initial & final ones not every batch on stability needs to be tested.

Sample QA Interview Question:What are the common variables in the manufacturing of tablets?
A.
· Particle size of the drug substance
· Bulk density of drug substance/excipients
· Powder load in granulator
· Amount & concentration of binder
· Mixer speed & mixing timings
· Granulation moisture content
· Milling conditions
· Lubricant blending times
· Tablet hardness
· Coating solution spray rate

Sample QA Interview Question: Whether bracketing & validation concept can be applied in process validation?
A.Both Matrixing & Bracketing’s can be applied in validation studies.
Matrixing
Different strength of same product
Different size of same equipment
Bracketting – Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds

1. What is an SOP ?

A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.

2. What is 21 CFR part 11 ?

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

 What are user requirements ?

User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.

4. What is a validation plan ?

Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:

Deliverables (Documents) to be generated during the validation process
Resources/Departments/Personnel to participate in the validation project
Time-Line for completing the validation project

5. What is an IQ document ?

Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.

6. What is an OQ Document ?

Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.

7. What is a PQ Document ?

Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

8. What is a Validation Summary Report ?

Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

A description of the validation project
All test cases performed, including if those test cases passed without issue
All deviations reported, including how those deviations were resolved

9. What is a Change Request ?

Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.

Sample QA Interview Question: Why water for pharmaceutical use is always kept in close loop in continuous circulation ?
A. Water is a best medium for many microorganisms, microorganism can be a highly pathogenic which causes serious diseases(many diseases are water born), these pathogens infect after consumption of contaminated water, microorganisms tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively.

Biofilms then can become a source of microbial contaminations; therefore purified water after collection in a distribution system is always kept in a closed loop in a continuous circulation.
A continuous circulation is also not enough at some points, therefore it is aided with high temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self sanitizing, but better assurance is obtained with a temperature of 80°C .

Purified water collected should be stored in a stainless still vessel which must facilitate distribution to the point of use in a closed loop of continuous circulation, tank should be made of corrosion free material of construction, and must facilitate sanitization and easy cleaning.

Quality Assurance Pharma Interview Questions – Part 3

Sample QA Interview Question: Water for pharmaceutical use shall be free cations,anions and other impurities why ?

A.Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals, and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts in degradation reaction of drug molecule, anions like chloride are highly active they participate in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucliophylic substitution reactions, which is also a reason why stability of drug is drastically affected in presence of cations and anions from mineral origin present in water.

Sample QA Interview Question: Water for pharmaceutical use shall be free heavy metals why ?
A. Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.

Sample QA Interview Question: Brazil falls under which climatic zone ?
A. Zone IVB (30 degree celsius and 75% relative humidity)

Sample QA Interview Question: Change in the size or shape of the original container requires any stability study?
A. Change in the size or shape of the original container may not necessitate the initiation of new stability study.

Sample QA Interview Question: Forced degradation(stress testing) and accelerated stability testing are same?
A. Forced degradation and stress testing are not same. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photo stability testing should be an integral part of stress testing.

Sample QA Interview Question: According to WHO guidelines what is the storage condition of climatic zone IVa and zone IVb?
A. Zone IV a: 30°C and 65% RH (hot and humid countries)
Zone IV b: 30°C and 75% RH (hot and very humid countries

Sample QA Interview Question: Countries comes under climatic zone IVb?
A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand

 

Pharmaceutical Industry Interview Questions pdf

Sample QA Interview Question: What is the purpose of stress testing in stability studies?
A. Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

Sample QA Interview Question: What is the formula for calculating number of air changes in an area?
A. Number of air changes/hour in an area is

= Total Room Airflow In CFM x 60
Total Volume of room in cubic feet
For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.

Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter

Then find Total air flow. Formula is
Total Air flow = Sum of air flow of individual filter.

Air flow Velocity can be measured with the help of Anemometer.

Sample QA Interview Question: What is dead leg?
A. A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.

Sample QA Interview Question: What is the recommended bio burden limits of purified water & WFI?
A. Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommended bio burden limit of 10 CFU/100 mL.
Sample QA Interview Question: Brief about ICH stabilty guidelines?
A. Q1A- Stability testing of new drug substance & products
Q1B- Photo stability testing of new drug substances & products
Q1C-Stability testing of new dosage forms
Q1D-Bracketing & Matrixing designs for testing of new drug substances and products
Q1E-Evaluation of stability data
Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)

Sample QA Interview Question: What is significant changes in stability testing?
A.
1. A 5% change in assay for initial value.

2. Any degradation products exceeds its acceptance
criterion.

3. Failure to meet acceptance criterion for
appearance,physical artributes and functionality
test.

4. Failure to meet acceptance criteria for dissolution
for 12 units.

Sample QA Interview Question: If leak test fail during in process checks what needs to be done ?
A.
Immediately stop packing process and check for
1.Sealing temperature
2.Verify for any possible changes like foil width,knurling etc.
3.Check & quarantine the isolated quantity of packed goods from last passed inprocess.
4.Collect random samples & do retest.
5.Blisters from the leak test passed containers shall allow to go further and rest must be deblistered/defoiled accordingly.

Sample QA Interview Question: How many Tablets shall be taken for checking friability?
A. For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.

Sample QA Interview Question: What is the formula for calculating weight loss during friability test?
A. %Weight loss = Initial Weight – Final Weight X 100
Initial Weight

Sample QA Interview Question: What is the pass or fail criteria for friability test?
A. Generally the test is run for once.If any cracked,cleaved or broken tablets present in the tablet sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is grater than the targeted value,the test should be repeated twice and the mean of the three tests determined.A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.

Sample QA Interview Question: What is the standard number of rotations used for friability test?
A. 100 rotations

Sample QA Interview Question: What is the fall height of the tablets in the friabilator during friability testing?
A. 6 inches.Tablets falls from 6 inches eight in each turn within the apparatus.

Sample QA Interview Question: Why do we check hardness during inprocess checks?
A. To determine need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time.If tablet is too hard, it may not disintegrate in the required period of time. And if tablet is too soft it will not withstand handling and subsequent processing such as coating,packing etc.

Sample QA Interview Question: What are the factors which influence tablet hardness?
A.
1.compression force
2.Binder quantity(More binder more hardness)
3.Moisture content

Sample QA Interview Question: Which type of tablets are exempted from Disintegration testing?
A. Chewable Tablets

Sample QA Interview Question: Which capsule is bigger in size – size ‘0’ or size ‘1’?
A. ‘0’ size

Sample QA Interview Question: What is the recommended temperature for checking DT of a dispersible tablet?
A. 25 ±10C (IP) & 15 – 250C (BP)

Sample QA Interview Question: What is mesh aperture of DT apparatus ?
A. 1.8 -2.2mm (#10)

Sample QA Interview Question: What is the pass/fail criteria for disintegration test?

A. If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.

Sample QA Interview Question: What is the recommended storage conditions for empty hard gelatin capsules?
A. 15 – 250C & 35 -55% RH

Sample QA Interview Question: Which method is employed for checking “Uniformity of dosage unit”?
A.
A.)Content uniformity
B.) Weight Variation
Weight variation is applicable for following dosage forms;Hard gelatin capsules,uncoated or film coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.

Sample QA Interview Question: What is the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus?
A. 28 – 32 cycles per minute.

Sample QA Interview Question: When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit?
A. Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia,and none can deviates more than twice that percentage.
Weight Variation limits for Tablets

IP/BP
Limit
USP
80 mg or less
10%
130mg or less
More than 80mg or Less than 250mg
7.5%
130mg to 324mg
250mg or more
5%
More than 324mg

Weight Variation limits for Capsules
IP
Limit
Less than 300mg
10%
300mg or More
7.5%

sugar syrup, ipqp , WTP and documentation. Tablet Interview Experience For 3Years In Qa ,  , In IPCA Model Of Quality Assurance C Stands For , Qc Interview Questions For Experienced , Pharma Qa Interview Questions And Answers For Freshers , Quality Assurance Interview Questions In Pharma Industry For Freshers , Quality Assurance Interview Question In Pharmaceutical Industry , In Interview May Ask Question On Validation Pharma Company , Qa Pharma Interview Questions , Pharma Qa Qc Interview Questions , Pharma Company QC Question , Pdf. SOP Of QA Chemist In Pharma , Pharmaceuitical QA Quetions , INTERVIEW QUESTIONS FOR QUALITY ASSURANCE CHEMIST

 , How To Record Recovery Of Last Batch In Pharma Industry , What Questions A Pharmaceutical QA Should Ask , Questions To Ask Quality Assurance Food Industry , Yhsm-Imp1 , Interview Question In Pharmaceuticals For Qa Dept , pharma QA interview question and answer, defination of quality assurance use in pharma industry, tablet interview experience for 3years in qa, quality assurance pharma interview questions, in IPCA model of quality assurance C stands for, qc interview questions for experienced, pharma qa interview questions and answers for freshers, quality assurance interview questions in pharma industry for freshers, basics of ipqa, quality assurance interview question in pharmaceutical industry, in interview may ask question on Validation pharma company, qa pharma interview questions, pharma qa qc interview questions, pharma company QC question, pdf. SOP of QA chemist in pharma

Pharmacology Notes: PPT PDF – ANTICANCER DRUGS – What is Cancer? Types/ Causes

Pharmacology Notes PPT PDF - ANTICANCER DRUGS - What is Cancer Types Causes

Pharmacology Notes

ANTICANCER DRUGS

Cancer cells have lost the normal regulatory mechanisms that control cell growth and multiplication.

What is Cancer?

• Cancer cell have lost their ability to differentiate (that means to specialize). Cancer refers to any one of a large number of diseases characterized by the development of abnormal cells that divide uncontrollably and have the ability to infiltrate and destroy normal body tissue. Cancer often has the ability to spread throughout your body.

Types of Cancer?

• Benign cancer cell stay at the same place
Malignant cancer cells invade new tissues to set up secondary tumors, a process known as metastasis

Causes of cancer

Common Causes of Cancer:

Smoking and Tobacco. Diet and Physical Activity. Sun and Other Types of Radiation. Viruses and Other Infections

• Chemicals causing cancer are called mutagens
• Cancer can be caused by chemicals, life style (smoking), and viruses

Gene mutations

A gene mutation can instruct a healthy cell to Allow rapid growth or Fail to stop uncontrolled cell growth or cells lose the controls (tumor suppressor genes) or even Make mistakes when repairing DNA errors

Definitions of cancer

genes that are related to cause cancer are called oncogenes.
Genes that become onogenic upon mutation are called protooncogenes.

Pharmacology Notes PPT PDF - ANTICANCER DRUGS - What is Cancer Types Causes

General signs and symptoms of cancer

Unexplained weight loss
Fever
Fatigue
Pain
Skin changes
Darker looking skin (hyperpigmentation)
Yellowish skin and eyes (jaundice)
Reddened skin (erythema)
Itching (pruritis)
Excessive hair growth
Change in bowel habits or bladder function
Long-term constipation, diarrhea,
Sores that do not heal
White patches inside the mouth or white spots on the tongue
Unusual bleeding or discharge
Thickening or lump in the breast or other parts of the body
Indigestion or trouble swallowing
Recent change in a wart or mole or any new skin change
Nagging cough or hoarseness

Top 10 Anti Cancer Drugs

anti cancer drugs list ppt pharmacology

List of Anti cancer Drugs

ALKYLATING AGENTS:

BUSULFAN
CARMUSTINE (BCNU)
CYCLOPHOSPHAMIDE
DACARBAZINE
LOMUSTINE (CCNU)
MECHLORETHAMINE
MELPHALAN
THIOTEPA

NATURAL PRODUCTS

BLEOMYCIN
DACTINOMYCIN
DAUNORUBICIN
DOXORUBICIN
ETOPOSIDE (VP-16)
IRINOTECAN
MITOMYCIN C
PACLITAXEL
VINBLASTINE
VINCRISTINE

MISCELLANEOUS:

Angiostatin
AMSACRINE
L-asparaginase
Bortezomib
CARBOPLATIN
CISPLATIN
Erlotinib
Gefitinib
Hydroxyurea
Imatinib
Pentostatin
PROCARBAZINE
Thalidomide

ANTIMETABOLITES:

Azathioprine
5-fluorouracil
6-thioguanine
6-mecaptopurine
Cytarabine (ara-c)
Gemcitabine
Methotrexate

IMMUNOTHERAPY:

Alemtuzumab
Aminoglutethimide
Bevacizumab
Cetuximab
Cyclosporine
Dexamethasone
Edrecolomab
Gemtuzumab
Ibritumomab
Interferon α
Interleukin 2
Interleukin-12
Prednisone
Rituximab
Tacrolimus (fk506)
Tositumomab
Trastuzumab
Tumour necrosis factor α

HORMONES and RELATED AGENTS:

Aminoglutethimide
Anastrozole
Exemestane
Flutamide
Letrozole
Goserelin
Leuprolide
Letrozole
Tamoxifen

SUPPORTING AGENTS:

Allopurinol
Erythropoietin
Filgrastim
Interleukin 11
Leucovorin
MESNA
Sargramostim (GM-CSF)

anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm pharmacology

Pharmacology anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm

anti neoplastic anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm

Anticancer drugs pharmacology pdf anticancer drugs list pdf classification of anticancer drugs wikipedia anticancer drugs classification ppt classification of anticancer drugs with mechanism of action classification of anticancer agents anticancer drugs classification mnemonics top 10 anti cancer drugs.

Pharmacology Notes -Apoptosis {CANCER} Steps Examples Pathway Mechanism Apoptosis vs Necrosis PDF PPT

What is Apoptosis PDF PPT.PNG

Pharmacology Notes

Apoptosis

Apoptosis is the programmed cell death. It is used by organisms to control the number of cells and tissue size. The cells during apoptosis shrink, but no uncontrolled release of cell debris into the environment occurs. The immune system usually “cleans up” the dying cells, and the content is recycled.

Apoptosis is triggered by an extracellular signal to the CD95 receptor. In response to that signal a set of cysteine proteases, called caspases are activated, that are largely responsible for the morphological changes observed.

Apoptosis Mechanism steps Examples Cancer & Apoptosis PPT PDF

Routes for Apoptosis:

•Two pathways for activation:
i) at the plasma membrane via external ligands upon binding to the death receptor or
ii) via the mitochondrial pathway

•Binding of external ligands such as tumor necrosis factor receptor (TNFα) to Fas receptors of the TNF superfamily induces receptor oligomerization and formation of a death-inducing signaling complex. This complex recruits, via the adaptor molecule FADD (Fas-associated death domain) multiple Pro-caspase-8 molecules, resulting in caspase-8 activation that finally results in caspase-3 activation

•In the mitochondrial pathway release of apoptogenic factors such as cytochrome c, Apaf-1, caspase-9-containing apoptosome complex and inhibitors-of-apoposis proteins trigger caspase-3 activation

• Links between the two pathways exist. 

What is Apoptosis PDF PPT.PNG

Apoptosis

Regulators of Apoptosis

• The Bcl-2 family of factors regulate caspase activation either negatively ( e.g. Bcl-2, Bcl-XL, MCL1) or positively (e.g. Bcl-XS, Bax,
BAD, BAK, BID)
• The inhibitors of apoptosis proteins (IAP) retard apoptosis
• Upstream modulators are oncogenes such as c-myc, that activates apoptosis in a manner important in cancer therapy • the tumor suppressor p53 induces apoptosis under certain circumstances 

Apoptosis {CANCER} Steps Examples Pathway Mechanism Apoptosis vs Necrosis PDF PPT

Terms:

Triggers Regulators Executioners
DNA damage
cytokine star vation
hypoxia
detachment
temperature
death receptor
p53
death domain factors
Bcl-2 family
Myc/oncogenes
cytokine-responsive kinases
Apaf-1
caspases
cytochrome c

Incoming Searches

apoptosis examples

apoptosis mechanism

why is apoptosis important

apoptosis steps

apoptosis pathway

apoptosis pdf

apoptosis cancer

apoptosis vs necrosis

Apoptosis vs Necrosis

• Necrosis is the uncontrolled (pathological) cell death. In contrast with apoptosis, cleanup of cell debris by phagocytes of the immune system is generally more difficult. There are many causes of necrosis including injury, infection, cancer, infarction, toxins and inflammation. Necrosis can arise from lack of proper care to a wound site. Usually cell outlines do not stay intact, and cell debris is released into the environment
• Apoptosis is the programmed cell death. It is used by organisms to control the number of cells and tissue size. The cells during apoptosis shrink, but no uncontrolled release of cell debris into the environment occurs. The immune system usually “cleans up” the dying cells, and the content is recycled. Apoptosis is triggered by an extracellular signal to the CD95 receptor. In response to that signal a set of cysteine proteases, called caspases are activated, that are largely responsible for the morphological changes observed.

Primary Drinking Water Standards – PDF EPA Magnesium Aluminum – Safe

Primary drinking water standards

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
ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
CryptosporidiumzeroTT3Gastrointestinal illness (such as diarrhea, vomiting, and cramps)Human and animal fecal waste
Giardia lambliazeroTT3Gastrointestinal illness (such as diarrhea, vomiting, and cramps)Human and animal fecal waste
Heterotrophic plate count (HPC)n/aTT3HPC 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
LegionellazeroTT3Legionnaire’s Disease, a type of pneumoniaFound naturally in water; multiplies in heating systems
Total Coliforms (including fecal coliform and E. Coli)

  • Quick reference guide
zero5.0%4Not a health threat in itself; it is used to indicate whether other potentially harmful bacteria may be present5Coliforms are naturally present in the environment; as well as feces; fecal coliforms and E. coli only come from human and animal fecal waste.
Turbidityn/aTT3Turbidity 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)zeroTT3Gastrointestinal 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

ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
Bromatezero0.010Increased risk of cancerBy-product of drinking water disinfection
Chlorite0.81.0Anaemia; infants and young children: nervous system effectsBy-product of drinking water disinfection
Haloacetic acids (HAA5)n/a60.060Increased risk of cancerBy-product of drinking water disinfection
Total Trihalomethanes (TTHMs)–> n/a6========–>–> 0.080Liver, kidney or central nervous system problems; increased risk of cancerBy-product of drinking water disinfection
Disinfectants

Quick reference guide: Stage 1 and 2 Disinfectants and Disinfection Byproducts Rules

ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
Chloramines (as Cl2)MRDLG=41MRDL=4.01Eye/nose irritation; stomach discomfort, anaemiaWater additive used to control microbes
Chlorine (as Cl2)MRDLG=41MRDL=4.01Eye/nose irritation; stomach discomfortWater additive used to control microbes
Chlorine dioxide (as ClO2)MRDLG=0.81MRDL=0.81Anaemia; infants and young children: nervous system effectsWater additive used to control microbes
 

Inorganic Chemicals

ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
Antimony0.0060.006Increase in blood cholesterol; decrease in blood sugarDischarge from petroleum refineries; fire retardants; ceramics; electronics; solder
Arsenic

  • Quick reference guide
  • Consumer fact sheet
00.010 as of 01/23/06Skin damage or problems with circulatory systems, and may have increased risk of getting cancerErosion of natural deposits; runoff from orchards, runoff from glass and electronics production wastes
Asbestos (fiber > 10 micrometers)7 million fibers per liter (MFL)7 MFLIncreased risk of developing benign intestinal polypsDecay of asbestos cement in water mains; erosion of natural deposits
Barium22Increase in blood pressureDischarge of drilling wastes; discharge from metal refineries; erosion of natural deposits
Beryllium0.0040.004Intestinal lesionsDischarge from metal refineries and coal-burning factories; discharge from electrical, aerospace, and defense industries
Cadmium0.0050.005Kidney damageCorrosion of galvanized pipes; erosion of natural deposits; discharge from metal refineries; runoff from waste batteries and paints
Chromium (total)0.10.1Allergic dermatitisDischarge from steel and pulp mills; erosion of natural deposits
Copper1.3TT7; Action Level=1.3Short 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)0.20.2Nerve damage or thyroid problemsDischarge from steel/metal factories; discharge from plastic and fertilizer factories
Fluoride4.04.0Bone disease (pain and tenderness of the bones); Children may get mottled teethWater additive which promotes strong teeth; erosion of natural deposits; discharge from fertilizer and aluminum factories
Lead

  • Quick reference guide
  • Rule information
zeroTT7; Action Level=0.015Infants 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)0.0020.002Kidney damageErosion of natural deposits; discharge from refineries and factories; runoff from landfills and croplands
Nitrate (measured as Nitrogen)1010Infants 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)11Infants 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
Selenium0.050.05Hair or fingernail loss; numbness in fingers or toes; circulatory problemsDischarge from petroleum refineries; erosion of natural deposits; discharge from mines
Thallium0.00050.002Hair loss; changes in blood; kidney, intestine, or liver problemsLeaching from ore-processing sites; discharge from electronics, glass, and drug factories
 

Organic Chemicals

ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
AcrylamidezeroTT8Nervous system or blood problems; increased risk of cancerAdded to water during sewage/wastewater treatment
Alachlorzero0.002Eye, liver, kidney or spleen problems; anemia; increased risk of cancerRunoff from herbicide used on row crops
Atrazine0.0030.003Cardiovascular system or reproductive problemsRunoff from herbicide used on row crops
Benzenezero0.005Anemia; decrease in blood platelets; increased risk of cancerDischarge from factories; leaching from gas storage tanks and landfills
Benzo(a)pyrene (PAHs)zero0.0002Reproductive difficulties; increased risk of cancerLeaching from linings of water storage tanks and distribution lines
Carbofuran0.040.04Problems with blood, nervous system, or reproductive systemLeaching of soil fumigant used on rice and alfalfa
Carbon tetrachloridezero0.005Liver problems; increased risk of cancerDischarge from chemical plants and other industrial activities
Chlordanezero0.002Liver or nervous system problems; increased risk of cancerResidue of banned termiticide
Chlorobenzene0.10.1Liver or kidney problemsDischarge from chemical and agricultural chemical factories
2,4-D0.070.07Kidney, liver, or adrenal gland problemsRunoff from herbicide used on row crops
Dalapon0.20.2Minor kidney changesRunoff from herbicide used on rights of way
1,2-Dibromo-3-chloropropane (DBCP)zero0.0002Reproductive difficulties; increased risk of cancerRunoff/leaching from soil fumigant used on soybeans, cotton, pineapples, and orchards
o-Dichlorobenzene0.60.6Liver, kidney, or circulatory system problemsDischarge from industrial chemical factories
p-Dichlorobenzene0.0750.075Anemia; liver, kidney or spleen damage; changes in bloodDischarge from industrial chemical factories
1,2-Dichloroethanezero0.005Increased risk of cancerDischarge from industrial chemical factories
1,1-Dichloroethylene0.0070.007Liver problemsDischarge from industrial chemical factories
cis-1,2-Dichloroethylene0.070.07Liver problemsDischarge from industrial chemical factories
trans-1,2-Dichloroethylene0.10.1Liver problemsDischarge from industrial chemical factories
Dichloromethanezero0.005Liver problems; increased risk of cancerDischarge from drug and chemical factories
1,2-Dichloropropanezero0.005Increased risk of cancerDischarge from industrial chemical factories
Di(2-ethylhexyl) adipate0.40.4Weight loss, liver problems, or possible reproductive difficulties.Discharge from chemical factories
Di(2-ethylhexyl) phthalatezero0.006Reproductive difficulties; liver problems; increased risk of cancerDischarge from rubber and chemical factories
Dinoseb0.0070.007Reproductive difficultiesRunoff from herbicide used on soybeans and vegetables
Dioxin (2,3,7,8-TCDD)zero0.00000003Reproductive difficulties; increased risk of cancerEmissions from waste incineration and other combustion; discharge from chemical factories
Diquat0.020.02CataractsRunoff from herbicide use
Endothall0.10.1Stomach and intestinal problemsRunoff from herbicide use
Endrin0.0020.002Liver problemsResidue of banned insecticide
EpichlorohydrinzeroTT8Increased cancer risk, and over a long period of time, stomach problemsDischarge from industrial chemical factories; an impurity of some water treatment chemicals
Ethylbenzene0.70.7Liver or kidneys problemsDischarge from petroleum refineries
Ethylene dibromidezero0.00005Problems with liver, stomach, reproductive system, or kidneys; increased risk of cancerDischarge from petroleum refineries
Glyphosate0.70.7Kidney problems; reproductive difficultiesRunoff from herbicide use
Heptachlorzero0.0004Liver damage; increased risk of cancerResidue of banned termiticide
Heptachlor epoxidezero0.0002Liver damage; increased risk of cancerBreakdown of heptachlor
Hexachlorobenzenezero0.001Liver or kidney problems; reproductive difficulties; increased risk of cancerDischarge from metal refineries and agricultural chemical factories
Hexachlorocyclopentadiene0.050.05Kidney or stomach problemsDischarge from chemical factories
Lindane0.00020.0002Liver or kidney problemsRunoff/leaching from insecticide used on cattle, lumber, gardens
Methoxychlor0.040.04Reproductive difficultiesRunoff/leaching from insecticide used on fruits, vegetables, alfalfa, livestock
Oxamyl (Vydate)0.20.2Slight nervous system effectsRunoff/leaching from insecticide used on apples, potatoes, and tomatoes
Polychlorinated biphenyls (PCBs)zero0.0005Skin changes; thymus gland problems; immune deficiencies; reproductive or nervous system difficulties; increased risk of cancerRunoff from landfills; discharge of waste chemicals
Pentachlorophenolzero0.001Liver or kidney problems; increased cancer riskDischarge from wood preserving factories
Picloram0.50.5Liver problemsHerbicide runoff
Simazine0.0040.004Problems with bloodHerbicide runoff
Styrene0.10.1Liver, kidney, or circulatory system problemsDischarge from rubber and plastic factories; leaching from landfills
Tetrachloroethylenezero0.005Liver problems; increased risk of cancerDischarge from factories and dry cleaners
Toluene11Nervous system, kidney, or liver problemsDischarge from petroleum factories
Toxaphenezero0.003Kidney, liver, or thyroid problems; increased risk of cancerRunoff/leaching from insecticide used on cotton and cattle
2,4,5-TP (Silvex)0.050.05Liver problemsResidue of banned herbicide
1,2,4-Trichlorobenzene0.070.07Changes in adrenal glandsDischarge from textile finishing factories
1,1,1-Trichloroethane0.200.2Liver, nervous system, or circulatory problemsDischarge from metal degreasing sites and other factories
1,1,2-Trichloroethane0.0030.005Liver, kidney, or immune system problemsDischarge from industrial chemical factories
Trichloroethylenezero0.005Liver problems; increased risk of cancerDischarge from metal degreasing sites and other factories
Vinyl chloridezero0.002Increased risk of cancerLeaching from PVC pipes; discharge from plastic factories
Xylenes (total)1010Nervous system damageDischarge from petroleum factories; discharge from chemical factories

Primary drinking water standards

Radio nuclides

Quick Reference Guide

ContaminantMCLG1(mg/L)2MCL or TT1(mg/L)2Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term)Sources of Contaminant in Drinking Water
Alpha particlesnone ———- zero15 picocuries per Litre (pCi/L)Increased risk of cancerErosion of natural deposits of certain minerals that are radioactive and may emit a form of radiation known as alpha radiation
Beta particles and photon emittersnone ———- zero4 millirems per yearIncreased risk of cancerDecay 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 ———- zero5 pCi/LIncreased risk of cancerErosion of natural deposits
Uraniumzero30 ug/L as of 12/08/03Increased risk of cancer, kidney toxicityErosion 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.

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

  1. Disinfect their water, and
  2. Filter their water, or
  3. 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)

Computers Questions & Answers M pharm B Pharm – 1 st 2nd Year D B M Pharmacy

Computers Questions & Answers M pharm B Pharm - 1 st 2nd Year D B M Pharmacy

1. Briefly describe the categories of computer networks?

Networks may be classified according to a wide variety of characteristics such as medium used to transport the data, communications protocol used, scale, topology, organizational scope, etc.

A communications protocol defines the formats and rules for exchanging information via a network. Well-known communications protocols are Ethernet, which is a family of protocols used in LANs, the Internet Protocol Suite, which is used not only in the eponymous Internet, but today nearly ubiquitously in any computer network

One way to categorize the different types of computer network designs is by their scope or scale. For historical reasons, the networking industry refers to nearly every type of design as some kind of area network. Common examples of area network types are:

LAN – Local Area Network
WLAN – Wireless Local Area Network
WAN – Wide Area Network
MAN – Metropolitan Area Network
SAN – Storage Area Network, System Area Network, Server Area Network, or sometimes Small Area Network
CAN – Campus Area Network, Controller Area Network, or sometimes Cluster Area Network
PAN – Personal Area Network
DAN – Desk Area Network
LAN and WAN were the original categories of area networks, while the others have gradually emerged over many years of technology evolution.

LAN – Local Area Network
A LAN connects network devices over a relatively short distance. A networked office building, school, or home usually contains a single LAN, though sometimes one building will contain a few small LANs (perhaps one per room), and occasionally a LAN will span a group of nearby buildings. In TCP/IP networking, a LAN is often but not always implemented as a single IP subnet.

In addition to operating in a limited space, LANs are also typically owned, controlled, and managed by a single person or organization. They also tend to use certain connectivity technologies, primarily Ethernet and Token Ring

WAN – Wide Area Network
As the term implies, a WAN spans a large physical distance. The Internet is the largest WAN, spanning the Earth.

A WAN is a geographically-dispersed collection of LANs. A network device called a router connects LANs to a WAN. In IP networking, the router maintains both a LAN address and a WAN address.

A WAN differs from a LAN in several important ways. Most WANs (like the Internet) are not owned by any one organization but rather exist under collective or distributed ownership and management. WANs tend to use technology like ATM, Frame Relay and X.25 for connectivity over the longer distances.

LAN, WAN and Home Networking

Residences typically employ one LAN and connect to the Internet WAN via an Internet Service Provider (ISP) using a broadband modem. The ISP provides a WAN IP address to the modem, and all of the computers on the home network use LAN (so-called private) IP addresses. All computers on the home LAN can communicate directly with each other but must go through a central gateway, typically a broadband router, to reach the ISP.

Other Types of Area Networks

While LAN and WAN are by far the most popular network types mentioned, you may also commonly see references to these others:
Wireless Local Area Network – a LAN based on WiFi wireless network technology
Metropolitan Area Network – a network spanning a physical area larger than a LAN but smaller than a WAN, such as a city. A MAN is typically owned an operated by a single entity such as a government body or large corporation.
Campus Area Network – a network spanning multiple LANs but smaller than a MAN, such as on a university or local business campus.
Storage Area Network – connects servers to data storage devices through a technology like Fibre Channel.
System Area Network – links high-performance computers with high-speed connections in a cluster configuration. Also known as Cluster Area Network.

Virtual private network

A virtual private network (VPN) is a computer network in which some of the links between nodes are carried by open connections or virtual circuits in some larger network (e.g., the Internet) instead of by physical wires. The data link layer protocols of the virtual network are said to be tunneled through the larger network when this is the case. One common application is secure communications through the public Internet, but a VPN need not have explicit security features, such as authentication or content encryption. VPNs, for example, can be used to separate the traffic of different user communities over an underlying network with strong security features.

VPN may have best-effort performance, or may have a defined service level agreement (SLA) between the VPN customer and the VPN service provider. Generally, a VPN has a topology more complex than point-to-point.

Network topology

A network topology is the layout of the interconnections of the nodes of a computer network. Common layouts are:
A bus network: all nodes are connected to a common medium along this medium. This was the layout used in the original Ethernet, called 10BASE5 and 10BASE2.
A star network: all nodes are connected to a special central node. This is the typical layout found in in a Wireless LAN, where each wireless client connects to the central Wireless access point.
A ring network: each node is connected to its left and right neighbor node, such that all nodes are connected and that each node can reach each other node by traversing nodes left- or rightwards. The Fiber Distributed Data Interface (FDDI) made use of such a topology.
A mesh network: each node is connected to an arbitrary number of neighbors in such a way that there is at least one traversal from any node to any other.
A fully connected network: each node is connected to every other node in the network.

Note that the physical layout of the nodes in a network may not necessarily reflect the network topology. As an example, with FDDI, the network topology is a ring (actually two counter-rotating rings), but the physical topology is a star, because all neighboring connections are routed via a central physical location.

2. Describe the basics of conducting a search?

Basic Search Techniques

This tutorial is a how-to guide for creating AND, OR, NOT, phrase, and field searches on Web search engines.

We’ll be using Google as an example. Keep in mind that the illustrated searches will work on most general search engines on the Web.

Tip! Before you read this tutorial, be sure that you understand the basics of Boolean logic. Check out Boolean Searching on the Internet. If you take the time to understand the basics of Boolean logic, you will have a better chance of search success.
Before you search, make a plan!

Putting together a search is a three-step process.

1. Identify your concepts

When planning your search, break down your topic into its separate concepts. Let’s say you’re interested in the effects of global warming on crops. In this case, you have two concepts: GLOBAL WARMING and CROPS.

2. Make a list of search terms for each concept

Once you have identified your concepts, list the terms which describe each concept. Some concepts may have only one term, while others may have many.

global warming
greenhouse effect
greenhouse gases
climate change

crops
crop yields
crop production
food supply

These lists are a suggestion. Depending on the focus of your search, there may be other terms more suited to what you’re looking for.

3. Specify the logical relationships among your search terms

Once you know the words you want to search, you need to establish the logical relationships among them using Boolean logic: AND, OR, NOT.

To keep things simple, you don’t need to use all the words you’ve compiled in a single search. The words are there to help you experiment with different searches until you find the results you want.

Phrase Search

Some words naturally appear in the context of a phrase, for example, freedom of the press. To search on phrases in most search engines, simply enclose the phrase within quotes: “freedom of the press”.

Phrases are especially important when there are stop words in your search. These are “little” words such as a, and, the, in, it, etc. Most search engines tend to ignore these words. If you want to be sure they are included in your search results, enclose them with the rest of your search within quotation marks. You can also put a plus sign (+) in front of them. Yahoo! suggests a combination of quotation marks and the plus sign, e.g., “+in thing”.
Field Search

Field searching is an optional way to focus your search results. With general search engines, you’re searching the full text of many millions of pages, and field searching can help you retrieve results that may be more manageable. For example, you can search for words that appear within a particular Web site, within the URL (Web address), in the page title, and so on. The exact technique for doing this can differ among search engines, so be sure to check out the Help pages before proceeding. Let’s consider a couple of examples on Google.
Title field

Computers Questions & Answers M pharm B Pharm - 1 st 2nd Year D B M Pharmacy

A title search can bring you more relevant results than merely searching for words that appear anywhere on the Web page. It’s more likely that a document that contains your search words in the title will be more relevant that a document that does not. For this reason, many search engines use title words as an important way of ranking search results in order of their relevancy.

Let’s look for Web pages that contain our search terms in the page title. Again, we’ll use Google to try this out, revisiting its advanced search page. Here, you need to open up the page to display all its options by clicking on the plus sign (+) near the bottom of the page next to the options for Date, usage rights, numeric range, and more.

Where your keywords show up gives you the option to select in the title of the page. Let’s search for hurricane caribbean deaths.

Notice that Google translated this search into allintitle: hurricane caribbean deaths. If you memorize this search syntax, you can conduct this search from Google’s main search page.

Site field

Searching on the site field is another useful way of finding relevant results. In this case, you search on the top-level and second-level domain names together, and then use AND logic to add topical words to your search.

You can read about domain structures in the tutorial A Basic Guide to the World Wide Web. Briefly, to take an example shown below: “nasa” is a second-level domain, and “gov” is a top-level domain.

Examples of sites:

nasa.gov
mit.edu
microsoft.com

Let’s look at an example of a site search. Let’s say you are searching for information about spacewalks conducted by NASA. Try this: spacewalks site:nasa.gov. This search will limit your results to pages on the NASA Web site.

Try this search yourself! You should get results that are similar to the ones shown in the screenshot below.

Notice that all the results come from the site nasa.gov. You can also go to the advanced search page on Google to conduct this search.

Natural language search

A few search engines encourage you to type your search as a “normal” question or sentence, rather than concern yourself with Boolean logic. This is sometimes known as a natural language search. On these engines, a variety of sophisticated techniques are working behind the scenes to analyze your search and return relevant results. Hakia is a good example of this type of engine. Give it a try and see what you think.

3.Define HTML? What does a basic HTML document contain?

HTML, which stands for HyperText Markup Language, is the predominant markup language for web pages. HTML is the basic building-blocks of webpages.
HTML is written in the form of HTML elements consisting of tags, enclosed in angle brackets (like <html>), within the web page content. HTML tags normally come in pairs like <h1> and </h1>. The first tag in a pair is the start tag, the second tag is the end tag (they are also called opening tags and closing tags). In between these tags web designers can add text, tables, images, etc.
The purpose of a web browser is to read HTML documents and compose them into visual or audible web pages. The browser does not display the HTML tags, but uses the tags to interpret the content of the page.
HTML elements form the building blocks of all websites. HTML allows images and objects to be embedded and can be used to create interactive forms.

Creating Your HTML Document

An HTML document contains two distinct parts, the head and the body. The head contains information about the document that is not displayed on the screen. The body then contains everything else that is displayed as part of the web page.

The basic structure then of any HTML page is:
<!DOCTYPE HTML PUBLIC “-//W3C//DTD HTML 3.2//EN”>
<html>
<head>
<!– header info used to contain extra information about
this document, not displayed on the page –>
</head>

<body>

<!– all the HTML for display –>
: :
: :
: :
</body>
</html>

4. Why do people go in for web site? Build a web site of your choice following the elements of a good web site?

If you are looking to promote your business to a lot of people nationally and internationally than website advertising is one of the best ways to do it. Every business in the world needs some kind of marketing strategy that can help the business owner to display his products and services to more and more people so that they are aware of it and that they feel that they need that product or service. In the earlier times, the world of advertisement was very much limited to radio and television that would cost a lot of money to the business owners because they had to get in touch with ad makers who would than come up with innovative ideas to make an ad.
However, things have changed considerably after the advent of Internet. The trend of Internet advertising has caught the attention of millions of business people all over the world because with the help of this technology you can reach billions of people and promote your business, product or services in affordable prices You can take a look at the rate at which websites are being developed which clearly indicates that people today are more interested in marketing their products through the medium of Internet rather than using old traditional methods of marketing.

5. What does a web server do? How does it work? How do you choose a web server platform?

web server can mean two things – a computer on which a web site is hosted and a program that runs on such a computer. So the term web server refers to both hardware and software. We’ll look at each of these individually.
The web server computer – the hardware

A web site is a collection of web pages which are digital files, typically written using HyperText Markup Language (HTML). For a web site to be available to everyone in the world at all times, it need to be stored or “hosted” on a computer that is connected to the internet 27/7/365. Such a computer is known as a Web Server (note the first letter is in uppercase).

You can potentially host a web site on your home computer but this involves a lot of work and constant monitoring. It is easier to “buy” web hosting from a company because there are thousands that offer this service.

There are several requirements for a Server computer – it needs to be fast, have a large storage capacity hard disk and lots of RAM. But the most important is having a permanent internet address also known as an I.P. (Internet protocol) address. If the I.P. address changes, the web site would not be found and will appear offline – the browser will display a cannot find web site error. For details, read differences between your home computer and a web Server.

Computers Questions & Answers M pharm B Pharm - 1 st 2nd Year D B M Pharmacy
The web server program – the software

A web server program is software that runs on the web site hosting Server computer. Its main purpose is to serve web pages; which means it waits for requests from web browsers (also known as clients) and responds by sending the required data back. This client-server interaction is the hallmark of the web!

There are many web server programs available- check list of web servers. The most famous and popular of all web servers is Apache developed by the Apache Foundation. Not only is Apache free but it’s also available for several operating systems including Windows, Macintosh and Linux/Unix.

FYI, differentiating the server program (software) and the Server computer (hardware) by the case of the first letter is suggested and followed only by purists – it is not a rule. Generally, readers quickly understand from the context whether one is referring to the hardware or the software.
What is the role of web server on the Internet?

Web servers – the computer or the program – have a vital role on the Internet. The Server machine hosts (stores) the web site on its hard disk while the server program helps deliver the web pages and their associated files like images and flash movies.

The process of loading a web site/page in a web browser starts with the user either entering the URL in the address bar or clicking on a link. You should know that each web page has a unique address (or URL) on the internet; which means the same page cannot exist in two places. (If a copy does exist in another location, its address would be different from that of the original).

The browser now needs to send out a request for the web page. Behind the scenes, the URL of the requested web page is resolved into an I.P. address, which, in English, means, converted to an I.P. address – something that computers understand. The I.P. address points to the location of the web site host and the request is forwarded to Server computer and passed on to the server software.

The server software now takes up and hunts for the requested web page on the hard disk. On finding the file, it sends a response and the web page file to the browser which then starts displaying the page. A typical web page not only has text but also embedded multimedia elements like images and Flash animation.

These “extra” files are separate from the actual web page and need to be sent one by one for the browser to display the web page correctly. Note (and an important one), ONLY the web browser determines how a web page is displayed; the web server has no control over this. The job of a web server ends once it processes the request from a browser and sends the required information.

Though the request-and-response process might seem to take time especially when you consider that the client and server computers might be thousands of miles apart, it actually happens very fast. That’s because of the HyperText Transfer Protocol (HTTP) which is a set of rules developed by the “big lads” to facilitate the transfer of data over the internet.
.

Every website needs a reliable web server to be hosted on, so that it can be accessed via internet users. Today, in web hosting market there are many types of web servers available running on different platform to select. types are There is a wide range of web servers running on different platform to choose from within the web hosting market today. As per the Netcraft, a company that keeps statistics on the leading web servers and the platforms on the Internet, the most popular platforms and web servers are:

• UNIX and Linux running Apache web server
• Window NT/2000 running Internet Information Server (IIS)
The other web server includes WebLogic, iPlanet, Sun ONE, Zeus and etc… Given the widespread popularity of Apache (closed to 60% market share) and Microsoft IIS (approximately 30%), you can almost guarantee you can find these two platforms are supported by most of the web hosting providers.
Operating systems are an importance piece of software that is required by each computer to be installed before it can function properly. Today, most of the personal computers are running on Microsoft Windows operating system: Win98, WinXP or Win2000.
Likewise, all web servers need operating system to perform different functionalities and different web servers run on different operating systems (or so called platforms). One of the most commonly found platform is UNIX that comes in various varieties that are popular with web hosts, including FreeBSD, NetBSD, OpenBSD and Linux. Another popular platform that has gained strong ground as a platform for web hosting market is Microsoft Windows 2000 and Windows Server 2003.
How do you choose your web server platform?
If your website is purely make up of static web pages (i.e. HTML files), then any web hosting platform will work fine for you. However, if your website allows dynamic content, you will most likely need to run specific server-side functionality such as CGI scripts, JSP, ASP, SSI or PHP. In this case, UNIX platform web hosting will be ideal for your requirement.
On the other hand, if you need to use specific applications that require Windows to run such as ASP, .Net, MS Access, Microsoft SQL server or Cold Fusion, then you will need to find a web hosting providers that support Microsoft’s Windows NT platform. Otherwise, all other server-side functionalities such as PHP, Perl and MySQL can be supported by UNIX platform.
While common programs such as Perl, PHP, Flash etc run on both UNIX and Window platform. Many other free open source software programs are available only for UNIX than for Windows. As a result, UNIX hosting is less expensive than Window hosting. So, if hosting cost is a big concern to you, then you should consider UNIX or Linux hosting.
If you have already decided on the type of design on your web pages, make sure you can find a web hosting plan that support your needs by reading the full features of the web hosting plan before you sign-up.

6.“The potential of world wide web (WWW) on the internet has led to an explosion in commercial activity”. Discuss.

As a commercial medium, the Web offers a number of important benefits which can be examined at both the customer and firm levels. In this way, we can address both demand and supply issues. We discuss the buyer benefits first, followed by the firm benefits. Buyer benefits arise primarily from the structural characteristics of the medium and include availability of information, provision of search mechanisms, and online product trial all of which can lead to reduced uncertainty in the purchase decision. Firm benefits arise from the potential of the Web as a distribution channel, a medium for marketing communications, and a market in and of itself. These efficiencies are associated with Web technology and the interactive nature of the medium.
1.1Consumer Benefits
One important consumer benefit associated with marketing on the Web is the access to greater amounts of dynamic information to support queries for consumer decision making. Hence marketing communications on the Web are more consumer-driven than those provided by traditional media.
In addition to the above, the advantages for industrial consumers are reduced costs to buyers from increased competition in procurement as more suppliers are able to compete in an electronically open marketplace. This increase in competition leads to better quality and variety of goods through expanded markets and the ability to produce customized goods (IITA 1994).

1.2. Benefits to the Firm

Distribution

Firm benefits arise partly from the use of the Web as a distribution channel. First, the Web potentially offers certain classes of providers participation in a market in which distribution costs or cost- of-sales shrink to zero. This is most likely for firms in publishing, information services or digital product categories (Jones 1995). For example, digital products can be delivered immediately, hence such businesses may encounter massive disintermediation or even the eventual elimination of middleman (Michalski 1995). Moreover buyers and sellers can access and contact each other directly, potentially elmininating some of the marketing cost and constraints imposed by such interactions in the terrestial world. This may also have the effect of shrinking the channel and making distribution much more efficient (mainly due to reduced overhead costs through such outcomes as uniformity, automation, and large-scale integration of management processes). Time to complete business transactions may be reduced as well, translating into additional efficiencies for the firm. However, such potential efficiencies must be tempered with market realities (Kline 1995).
Second, business on the Web transfers more of the selling function to the customer, through online ordering and the use of fill-out-forms (Michalski 1995) thus helping to bring transactions to a conclusion. This permits a third benefit in the form of capture of customer information. The technology offers the firm the opportunity to gather market intelligence and monitor consumer choices through customers’ revealed preferences in navigational and purchasing behavior in the Web. Note however that there are many social, legal and technological issues and drawbacks at the present level of technology which prevent the full capitalization of this benefit (see, for example, Caruso 1995).
Marketing Communications

At the present time, most firms use the Web primarily to deliver information about the firm and its offerings and for both internal and external communication (Magid 1995, Sharples 1995) with other firms and consumers. The interactive nature of the medium (see Hoffman & Novak 1995 for discussion) offers another category of firm benefits since it is especially conducive to developing customer relationships. This potential for customer interaction, which is largely asynchronous under current implementations, facilitates relationship marketing and customer support (Cuneo 1995) to a greater degree than ever before possible with traditional media.

Web sites are available on demand to consumers 24 hours a day. The interactive nature of the medium can be used by marketers to hold the attention of the consumer by engaging the consumer in an asynchronous “dialogue” that occurs at both parties’ convenience. This capability of the medium offers unprecedented opportunities to tailor communications precisely to individual customers, allowing individual consumers to request as much information as each desires. Further, it allows the marketer to obtain relevant information from customers for the purposes of serving them more effectively in the future.

The simplest implementations involve engaging customers through the use of email buttons located strategically on the site. More sophisticated implementations may involve fill-out- forms and other incentives designed to engage customers in ongoing relationships with the firm. The objective of such continuous relationship-building is dual-pronged: to give consumers information about the firm and its offering and to receive information from consumers about their needs with respect to such offerings. Hence, effective customized advertising, promotion and customer service (Berniker 1995) is the fifth benefit that the commercial Web offers to the firm.

Operational Benefits

Operational benefits of Web use for industrial sellers are reduced errors, time, and overhead costs in information processing; reduced costs to suppliers by electronically accessing on-line databases of bid opportunities, online abilities to submit bids, and online review of awards.

7. Discuss the uses of Internet activity?

Americans spend nearly a quarter of their time online on social networking sites and blogs, up from 15.8 percent just a year ago (43 percent increase) according to new research released today from The Nielsen Company. The research revealed that Americans spend a third their online time (36 percent) communicating and networking across social networks, blogs, personal email and instant messaging.
Top 10 Sectors by Share of U.S. Internet Time
1 Social Networks
2 Online Games
3 E-mail
4 Portals
5 Instant Messaging
6 Videos/Movies
7 Search
8 Software Manufacturers
9 Multi-category Entertainment
10 Classifieds/Auctions

Internet has become a part of our everyday life. From being used in defense purposes by the United States military for communication initially, to being used worldwide for hundreds of thousands of different purposes, internet has come a long way. Internet is there to stay with us and has taken a place where it is a part of our every day life now.

There are millions of applications of internet. We are in fact as dependent on internet as we are on other utility things like electricity, water etc. In fact many people would think that a part of their life is missing if they are not able to log on for even one day.

Before a few years, people used to get up in the morning and read the newspaper or watch television. Now most people log onto the internet first thing in the morning. So when internet has become so essential in our daily life, what are the things that can be done on the internet and what are it’s many uses?

The following are a list of some of the major uses of the internet :

1. Search engine :
It can be used to search anything and everything. Most popular search engines are google and yahoo searches.

2. Shopping:
Shopping has become easier with the advent of internet. You can buy or sell online.

3. Communication :
This is a major role of the internet. It helps people to communicate either with the use of social networking websites or through e mails. Even chatting is a major use of the internet.

4. Job search:
Nowadays, many people search for their jobs online as it is quicker and there is a larger variety of job vacancies present.

5. Hobbies:
Those who are having certain hobbies can try to improve on it by reading up on many aspects of their hobby.

6. Research: Research papers are present online which helps in the researcher doing a literature review.

7. Studying:
Now right from kinder garden children are exposed to internet and computers. They find many useful things to learn on the internet(though with supervision). Upto doctorate level education, people rely on internet for their education. Online educational books have even reduced the need for a library.

These are only some of the uses of the internet. There are so many more that will can be listed forever. There are also negative aspects of the internet. But the onus is on the user to make use of the internet for it’s benefits and leave all the negative aspects.

Advantages of internet :-

There many advantages to using the internet such as:
Email.
E-mail is an online correspondence system. With e-mail you can send and receive instant electronic messages, which works like writing letters. Your messages are delivered instantly to people anywhere in the world, unlike traditional mail that takes a lot of time. Email is now an essential communication tools in business. It is also excellent for keeping in touch with family and friends. The advantages to email is that it is free ( no charge per use) when compared to telephone, fax and postal services.

Information.
The Internet is a virtual treasure trove of information. Any kind of information on any topic under the sun is available on the Internet. The ‘search engines’ on the Internet can help you to find data on any subject that you need.
There is a huge amount of information available on the internet for just about every subject known to man, ranging from government law and services, trade fairs and conferences, market information, new ideas and technical support.

Services.
Many services are now provided on the internet such as online banking, job seeking and applications, and hotel reservations. Often these services are not available off-line or cost more.

Buy or sell products

The internet is a very effective way to buy and sell products all over the world. Along with getting information on the Internet, you can also shop online. There are many online stores and sites that can be used to look for products as well as buy them using your credit card. You do not need to leave your house and can do all your shopping from the convenience of your home.

Communities.

Communities of all types have sprung up on the internet. Its a great way to meet up with people of similar interest and discuss common issues.

Online Chat:
There are many ‘chat rooms’ on the web that can be accessed to meet new people, make new friends, as well as to stay in touch with old friends.

Downloading Software:
This is one of the most happening and fun things to do via the Internet. You can download innumerable, games, music, videos, movies, and a host of other entertainment software from the Internet, most of which are free.

8. How is internet used by legal practitioners?

The use of the Internet and its component part, the World Wide Web, has grown tremendously in recent years.

Lawyers and others seeking legal information have not been left out in the cold in terms of legal information available on the Internet. Currently available for free are court cases, statutes, regulations, publications, and decisions and orders.

Materials are available not only from federal government sources, but also from state and local sources. This article will look at legal resources on the Internet, how to find them, and what to look for when you do find them.

There are a number of ways to locate legal information on the Internet. One is to use columns or articles in traditional publications. Another is to search the Internet using Web sites established for this purpose, called “search engines.” Lawyers also can refer to the myriad Web sites with lists of legal resources available (resource listings that allow you to click and be taken to another site are called “links”) to find resources of interest.

Searching the Internet. Legal information on the Internet can be found either using “general” or “generic” search engines, or using law- and legal-specific resources. When using generic search engines, searches are best conducted using general descriptive terms such as “computer law” or “employment law” to find Web sites that contain information related to a specific legal topic.

Unless a case or legal concept is extremely well known, searching generic search engines using specific legal terms may not work well (returning no links or returning so many as not to be useful).

Searching generic search engines for specific resources such as the U.S. Supreme Court or the New York State Assembly probably will provide good results. While utilizing generic search engines may help get to general area concepts and sites, using the more specific legal search engines likely will provide more efficient results when searching for specific legal information.

Information and help on searching can be found at “The Spider’s Apprentice” http://www.monash.com/spidap.html. (Because the World Wide Web often is called just “the Web,” allusions to “spiders” that “crawl around” the Web are common). The State University at Albany also maintains a site dedicated to search engines, including descriptions of the various search engines and the data they contain at http://www.albany.edu/library/internet/engines.html.

Using listings and directories.

Many of the generic and legal-specific search engines also contain indices or directories of information organized by topic. Add to these the plethora of sites that list only legal resources–without the ability to undertake the Web-wide database searches offered by the search engines– and the searching attorney should find more than adequate direction in undertaking legal research on the Internet. Attorneys often find a specific legal site that works best for them, and “bookmark” or choose such site as a “favorite” to start from when conducting legal research.

Other resources on the Web.

In addition to search engines, links and directories, there is a tremendous wealth of organizational and secondary material on the Internet. Legal news can be found, often from “name brand” publications updated daily (or even more frequently). Bar associations, often with resources and link pages of their own, also are on the Web, offering member services and information designed to assist their lawyer membership.

A note of caution about using secondary sources is that the Web does not discriminate based on content, quality or accuracy of information. Anyone with a Web account, appropriate software and a little bit of knowledge, can have a Web page. Before relying upon something you have found on the Web other than primary authority obtained from a verified source, read it extremely critically.

There are reported occasions where non-lawyers have put up legal sites (often related to litigation they themselves have gone through) with inaccurate information. Even reputable sources such as daily legal news producers have included articles with inaccurate information.

One legal news site recently included an article on attorney-client privilege and e-mail and stated that New York had considered–but not adopted–a change in the law to protect such communications. In fact, New York did adopt that law in 1998, and after notification the article has been changed to reflect the true state of the law.

Because Web publishing is not subject to the same requirements as print publications, often even skimping in the area of editing and review of content, attorneys need to be careful not to rely too heavily on information found at “unofficial” or secondary sites.

In using cases and statutes, make certain to get the text from an approved or official site. If using secondary materials from a publication that is otherwise in print (such as a law review), this concern is diminished.

9.Define networking? Highlight the issues of network security?

A computer network, often simply referred to as a network, is a collection of computers and devices interconnected by communications channels that facilitate communications and allows sharing of resources and information among interconnected devices. Put more simply, a computer network is a collection of two or more computers linked together for the purposes of sharing information, resources, among other things. Computer networking or Data Communications (Datacom) is the engineering discipline concerned with computer networks. Computer networking is sometimes considered a sub-discipline of electrical engineering, telecommunications, computer science, information technology and/or computer engineering since it relies heavily upon the theoretical and practical application of these scientific and engineering disciplines
Businesses are using networking for communication with clients and employees and Make a productive, innovative, shared work environment. So sometimes they ignore many security issues to get the network up and running. The following are a few common network security issues which are ignored by the owner.
1. Improper/weak passwords. The Password is simplest form of security. By leaving passwords easy(i.e., password/admin/your name/mobile no. or city ), unauthorized Hackers are practically invited to view Important data. Passwords are more secure when they contain both letters and numbers in a combination of upper-case and lower-case characters, special character and they should be changed periodically.
2. Lack of education. Educated users in the use of their Services, especially with regard to e-mail, attachments, and downloads. They need to know exactly what kinds of threats are out there. Uneducated computer users are often those who fall victim to malware’s, spywares, keyloggers, viruses, and phishing attacks, all of which are designed to Harm the systems or leak personal details like passwords, login details to a third party without the user’s permission.
3. No backups. Idleness is one of the biggest security threats. It’s considerably more difficult to completely re-create a crippled system than it is to take the time to take proper backups of your data. Create backups often, and do not immediately overwrite or delete them with the next set of backups. In advance, make copies of backup’s and keep them off-site in case of emergency.
4. Plug and surf. Unfortunately, computers are not designed to be connected to the Internet straight out of the box. Before a phone line, Ethernet cable, or wireless Device is anywhere near a new computer, install a line of Protection software. So this should include Protection from viruses, multiple spyware scanners, and a program that runs in the background to prevent malicious software from ever being installed.
5. Not updating. What good are all those virus and spyware scanners if they’re not updated? It’s very important to update what are called the “virus/spyware databases” every week. This keeps the scanners up-to-date to detect the latest Viruses and malicious software’s.
6. Ignoring security patches. Security holes may exist in your so perating System. No software is perfect. Once an vulnerability or hole is found, it’s usually exploited within a very short period of time. Therefore, it is imperative to install security patches as soon as possible in your system.
7. Trust. Ads on the Internet have become tortuous and illusive. They now appear as “urgent system error messages” and warnings designed to scare users into clicking. As a rule of thumb, if a popup window contains an ad claiming to end popups, chances are it’s a scam.
8. Not using encryption. Encryption is very important when dealing with online banking and credit cards payments. Storing and transferring unencrypted data is the equivalent of posting that data for everyone to see. If you’re not comfortable implementing encryption technology, have an IT specialist assist you.
9. Trying to do it all yourself. Setting up a network, applying proper security measures, and downloading and installing software can be tricky. Large companies have IT departments. Small business owners should also ask for advice or even hire help. It’s worth the extra cost.
10. Proper instruction. Security measures are most effective if everyone is aware of how the system works. Give employees a brief overview of the security measures they’re expected to follow.
So these are a few common network security issues which should not ignore by a good business owner

10.“Security is a term with both a business meaning and a technical meaning”. Discuss the statement in terms of security basics?

10. “Security is a term with both a business meaning and a technical meaning”. Discuss the statement in terms of security basics?

Security Management for networks is different for all kinds of situations. A home or small office would only require basic security while large businesses will require high maintenance and advanced software and hardware to prevent malicious attacks from hacking and spamming.
Homes & Small Businesses
• A basic firewall or a unified threat management system.
• For Windows users, basic Antivirus software. An anti-spyware program would also be a good idea. There are many other types of antivirus or anti-spyware programs out there to be considered.
• When using a wireless connection, use a robust password. Also try to use the strongest security supported by your wireless devices, such as WPA2 with AES encryption.
• If using Wireless: Change the default SSID network name, also disable SSID Broadcast; as this function is unnecessary for home use. (However, many security experts consider this to be relatively useless. http://blogs.zdnet.com/Ou/index.php?p=43 )
• Enable MAC Address filtering to keep track of all home network MAC devices connecting to your router.
• Assign STATIC IP addresses to network devices.
• Disable ICMP ping on router.
• Review router or firewall logs to help identify abnormal network connections or traffic to the Internet.
• Use passwords for all accounts.
• Have multiple accounts per family member, using non-administrative accounts for day-to-day activities. Disable the guest account (Control Panel> Administrative Tools> Computer Management> Users).
• Raise awareness about information security to children.[5]
Medium businesses
• A fairly strong firewall or Unified Threat Management System
• Strong Antivirus software and Internet Security Software.
• For authentication, use strong passwords and change it on a bi-weekly/monthly basis.
• When using a wireless connection, use a robust password.
• Raise awareness about physical security to employees.
• Use an optional network analyzer or network monitor.
• An enlightened administrator or manager.
Large businesses
• A strong firewall and proxy to keep unwanted people out.
• A strong Antivirus software package and Internet Security Software package.
• For authentication, use strong passwords and change it on a weekly/bi-weekly basis.
• When using a wireless connection, use a robust password.
• Exercise physical security precautions to employees.
• Prepare a network analyzer or network monitor and use it when needed.
• Implement physical security management like closed circuit television for entry areas and restricted zones.
• Security fencing to mark the company’s perimeter.
• Fire extinguishers for fire-sensitive areas like server rooms and security rooms.
• Security guards can help to maximize security.

What is IPR? Patent & Process of filing a Patent Application

What is IPR Patent Process of filing a Patent Application

The purpose of a patent is to provide a form of protection for technological advances.  The theory is that patent protection will provide a reward not only for the creation of an invention, but also for the development of an invention to the point at which it is technologically feasible and marketable, and that this type of an incentive would promote additional creativity and encourage companies to continue their development of new technology to the point at which it is marketable, useful to the public and desirable for the public good.

 

The Patent system in India is governed by the Patents Act, 1970 (No 39 of 1970) & The Patents Rules 1972, effective from April 20,1972. Subsequently The Patents Act, 1970 is amended effective from January 1, 1995 & The Patents Rules, 1972 is amended effective from June 2, 1999.

DOCUMENTS REQUIRED FOR FILING AN PATENT APPLICATION

Application form in triplicate.

Provisional or complete specification in triplicate. If the provisional specification is filed it must be followed by complete specification within 12 months (15 months with extension).

Drawing in triplicate (if necessary).

Abstract of the invention (in triplicate).

Information and undertaking listing the number, filing date and current status of each foreign patent application in duplicate.

Priority document (if priority date is claimed).

Declaration of inventorship where provisional specification is followed by complete specification or in case of convention application.

Power of attorney (if filed through Patent Agent).

Fee in cash/by local cheque/by demand draft.

Where to apply? OFFICE FOR FILING AN APPLICATION

Application is required to be filed according to the territorial limits where the applicant or the first mentioned applicant in case of joint applicants for a patent normally resides or has domicile or has a place of business or the place from where the invention actually originated .If the applicant for the patent or party in a proceeding having no business, place or domicile in India., the appropriate office will be according to the address of service in India given by the applicant or party in a proceeding.

EXAMINATION & PUBLICATION

All the applications for patent accompanied by complete specification are examined substantively. A first examination report stating the objection(s) is communicated to the applicant or his agents. Application or complete specification may be amended in order to meet the objection(s). Normally all the objections must be met within 15 months from the date of first examination report. Extension of time for three months is available, but application for extension therefore must be made before the expiry of normal period of 15 months. If all the objections are not complied with within the normal period or within the extended period the application will be deemed to have been abandoned. When the application is found to be suitable for acceptance it is published in the gazette of India (Part III, Section2). It is deemed laid open to the public on the date of publication in the gazette of India.

OPPOSITION

Notice of opposition must be filed within four months of notification in the Gazette. Extension of one month is available, but must be applied for before expiry of initial four month period.

Process of Grant or Sealing of PATENT

If the application is not opposed or the opposition is decided in favour of the applicant or is not refused the patent is granted or sealed on payment of sealing fee within 6 months from the date of advertisement. However, it is extendable by three months.

REGISTER OF PATENTS

The Register of Patents will be kept in the Patent Office and its branch offices. Register of Patents can be inspected or extract from it can be obtained on payment of prescribed fee. Register of Patents contains full details of the Patent which include Patent number, the names and addresses of the patentee; notification of assignment etc.; renewals, particulars in respect of proprietorship of patent etc.

RIGHTS OF PATENTEE

A patent grant gives the patentee the exclusive right to make or use the patented article or use the patented process. He can prevent all others from making or using the patented process. A patentee has also the right to assign the patent, grant licenses under, or otherwise deal with it for any consideration. These rights created by statute are circumscribed by various conditions and limitations.

RENEWAL FEE

Renewal fees are payable every year. The first renewal fee is payable for third year of the patent’s life, and must be paid before the patent’s second anniversary. If the patent has not been issued within that period, renewal fees may be accumulated and paid immediately after the patent is sealed, or within three months of its recordal in the Register of the Patents.

Date of payment of Renewal fees is measured from the date of the patent. Six months’ grace is available with Extension fee. No renewal fees are payable on patents of addition, unless the original patent is revoked and the patent of addition is converted into an independent patent; renewal fees then become payable for the remainder of the term of the main patent.

No renewal fees are payable during the pendency of the application for a patent; renewal fees that become overdue during pendency are payable upon sealing within three months of recordal in the Patent Register.

What is IPR Patent Process of filing a Patent Application

WORKING

Annual reports as to the extent of working, by every patentee and licensee, are a statutory requirement and must be submitted by March, 31 each year for the previous year ending December, 31.

COMPULSORY LICENSE AND LICENSE OF RIGHT

On failure to work a patent within three years from the date of its sealing, an interested party may file petition for grant of a compulsory license.

Every patent for an invention relating to a method or process for manufacture of substances intended for use, or capable of being used, as food, medicines, or drugs, or relating to substances prepared or produced by chemical process (including alloys, optical glass, semi-conductors and inter-metallic compounds) shall be deemed to be endorsed “Licenses of Right” from the date of expiry of three years from the date of sealing the patent.

ASSIGNMENT

Applications must be filed on the prescribed form with the Controller for the registration of assignments and any other documents creating an interest in a patent in order for them to be valid. In order to be valid, an assignment must be recorded within six months from the date of the document. A six-months extension may be obtained.

LICENSE

Applications must be filed on the prescribed form with the Controller for the registration of licenses and any other documents creating an interest in a patent in order for them to be valid. A license must be recorded within six months from the date of the document.

DURATION

A patent lasts for 14 years from the date of filing the complete specification (if an application is filed with provisional specification on January 1, 1989, and a complete specification is filed on January 1, 1990, the duration is counted from January 1, 1990). However, for food, drug and insecticide patents, the life is seven years from the date of complete specification, or five years from date of sealing, whichever is shorter.

RESTORATION

Application for restoration of a patent that lapses due to nonpayment of renewal fees must be made within one year of lapse. If an overdue annuity is not paid within the extension period, the one-year period for seeking restoration commences from the date of recordal.

INFRINGEMENT

Infringement can consist of taking away essential features of the patented invention; utilizing claimed features; copying patented substances; mechanical equivalence; taking part of the invention. while the patent is in force. Use by the government or for government purposes is not infringement. Such use must be paid for on terms to be agreed upon before or after use. Accidental or temporary use, use for research, use on foreign vessels, do not constitute infringement.

APPEAL

Appeal lies in the High Court. Appeal must be lodged within three months from the decision of the Controller.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

What is Homology Modelling?

Homology modelling allows users to safely use rapidly generated in silico protein models in all the contexts where today only experimental structures provide a solid basis: structure-based drug design, analysis of protein function, interactions, antigenic behavior, and rational design of proteins with increased stability or novel functions. In addition, protein modeling is the only way to obtain structural information if experimental techniques fail. Many proteins are simply too large for NMR analysis and cannot be crystallized for X-ray diffraction.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Among the major approaches to three-dimensional (3D) structure prediction, homology modeling is the easiest one.
In the Homology Modelling, structure of a protein is uniquely determined by its amino acid sequence (Epstain, Goldberger, and Anfinsen, 1963). Knowing the sequence should, at least in theory, suffice to obtain the structure.
2. During evolution, the structure is more stable and changes much slower than the associated sequence, so that similar sequences adopt practically identical structures, and distantly related sequences still fold into similar structures. This relationship was first identified by Chothia and Lesk (1986) and later quantified by Sander and Schneider (1991). Thanks to the exponential growth of the Protein Data Bank (PDB), Rost (1999) could recently derive a precise limit for this rule. As long as the length of two sequences and the percentage of identical residues fall in the region marked as “safe,” the two sequences are practically guaranteed to adopt a similar structure.

Homology Modelling or Protein Modelling Example

Imagine that we want to know the structure of sequence A (150 amino acids long,). We compare sequence A to all the sequences of known structures stored in the PDB (using, for example, BLAST), and luckily find a sequence B (300 amino acids long) containing a region of 150 amino acids that match sequence A with 50% identical residues. As this match (alignment) clearly falls in the safe zone (Fig. 25.1), we can simply take the known structure of sequence B
(the template), cut out the fragment corresponding to the aligned region, mutate those amino acids that differ between sequences A and B, and finally arrive at our model for structure A. Structure A is called the target and is of course not known at the time of modeling.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT

Homology Modelling Steps

In practice, homology modeling is a multistep process that can be summarized in seven steps:
1. Template recognition and initial alignment
2. Alignment correction
3. Backbone generation
4. Loop modeling
5. Side-chain modeling
6. Model optimization
7. Model validation

At almost all the steps choices have to be made. The modeler can never be sure to make the best ones, and thus a large part of the modeling process consists of serious thought about how to gamble between multiple seemingly similar choices. A lot of research has been spent on teaching the computer how to make these decisions, so that homology models can be built fully automatically. Currently, this allows modelers to construct models for about 25% of the amino acids in a genome, thereby supplementing the efforts of structural genomics projects.

Homology_Modelling – Protein PPT

homology modeling

Protein Homology modelling steps ppt Structures

Homology Modelling Steps, Homology Modelling Software, Homology Modelling Ppt, Homology Modelling Pdf, Homology Modeling Server, Protein Modelling Bioinformatics, Homology Modeling Tutorial, Homology Modelling Slideshare

“Scientific discoveries are not the same as inventions” #M. Pharmacy Notes IPR Material

#M. Pharmacy Notes IPR Material

Scientific discoveries are not the same as inventions Do you agree? Substantiate your answer.

Invention makes or develops something that did not exist. Discovery finds real (non-abstract) things that are already exsistant Patentable inventions must — under conventional patent law — be new, useful and involve an ‘inventive step’. In contrast, it is generally accepted that utilizing something that already exists in nature is a ‘discovery’, and is therefore not patentable.

Drawing an appropriate boundary between un-patentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle.

#M. Pharmacy Notes IPR Material
Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headlinegrabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that government and/or the courts will address the issue, and perhaps substantially shift the boundary.
The question of what should and should not be patentable subject matter has spawned a number of battlegrounds in recent years, setting against each other those in each area supporting patentability, claiming that patents would cause increased innovation and public good, against opponents with views that patentability was being sought only for private good but would do public harm.

Flashpoints have included the patenting of naturally occurring biological material; genetic sequences; stem cells; “traditional knowledge”; programs for computers; business methods.

In March 2010, a federal district court judge in the Southern District of New York ruled that purified DNA sequences and the inventions using them are unpatentable. As has been discussed Judge Sweet relied entirely upon Supreme Court precedent and ignored contrary case law of the Federal Circuit Court of Appeals to conclude that isolated DNA is of the same fundamental quality as natural DNA and is thus unpatentable under section 101 of the Patent Act; and that the method claims of the patents were abstract mental processes that were also unpatentable. His rationale is controversial and his ruling has been appealed to the Federal Circuit.
In the process, different jurisdictions have come to different views as to what should be allowed and what should not.

Types of Patents – All about Patents – Intellectual Property Rights & Regulatory Affairs notes

Patents on business methods have proven to be a particularly controversial type of statutory subject matter. They have been criticized because the patents granted are perceived as being too broad, perhaps due to the difficulty in searching for prior art and recruiting suitably qualified patent examiners who have historically had a science background rather than a business background. Patent applications for business methods are also subject to delays in prosecution at the United States Patent and Trademark Office and other patent office

ANATOMY & PHYSIOLOGY Of Human Respiratory Tract

ANATOMY & PHYSIOLOGY Of Human Respiratory Tract

Anatomy and Physiology Of human respiratory system is a complicated organ system of very close structure– function relationships. The system consisted of two regions: the conducting airway and the respiratory region. The airway is further divided into many folds: nasal cavity and the associated sinuses, and the nasopharynx, oropharynx, larynx, trachea, bronchi, and bronchioles. The respiratory region consists of respiratory bronchioles, alveolar ducts, and alveolar sacs.

ANATOMY AND PHYSIOLOGY OF HUMAN RESPIRATORY TRACT:

               The respiratory system works with the circulatory system to deliver oxygen from the lungs to the cells and remove carbon dioxide, and return it to the lungs to be exhaled. The exchange of oxygen and carbon dioxide between the air, blood and body tissues is known as respiration. Healthy lungs take in about 1 pint of air about 12–15 times each minute. All of the blood in the body is passed through the lungs every minute. The respiratory tract is divided into two main parts: the upper respiratory tract, consisting of the nose, nasal cavity and the pharynx; and the lower respiratory tract consisting of the larynx, trachea, bronchi and the lungs The trachea, which begins at the edge of the larynx, divides into two bronchi and continues into the lungs. The trachea allows air to pass from the larynx to the bronchi and then to the lungs. The bronchi divide into smaller bronchioles which branch in the lungs forming passageways for air. The terminal parts of the bronchi are the alveoli. The alveoli are the functional units of the lungs and they form the site of gaseous exchange     

ANATOMY & PHYSIOLOGY Of Human Respiratory Tract

            The blood barrier between the alveolar space and the pulmonary capillaries is very thin to allow for rapid gas exchange. During inspiration, oxygen diffuses through the alveoli walls and the interstitial space, into the blood. Carbon dioxide diffuses in the opposite direction during exhalation. Alveoli are small and there are approximately 300 million of them in each lung. Although alveoli are tiny structures, they have a very large surface area in total (~100 m2) for performing efficient gas exchange.

                     The alveoli form a honeycomb of cells around the spiral, cylindrical surface of the alveolar duct. The exposed alveolar surface is normally covered with a surface film of lipoprotein material.

                      There are several types of pulmonary alveolar cells. Type I (or small type A), are non-phagocytic, membranous pneumocytes. These surface-lining epithelial cells are approximately 5 μm in thickness and possess thin squamous cytoplasmic extensions that originate from a central nucleated portion. These portions do not have any organelles and hence they are metabolically dependent on the central portion of the cell. This reduces their ability to repair themselves if damaged. Attached to the basement membrane are the larger alveolar cells (Type II, type B or septal cells). These rounded, granular, epithelial pneumocytes are approximately 10 to 15 μm tick. There are 6 to 7 cells per alveolus and these cells possess great metabolic activity. They are believed to produce the surfactant material that lines the lung and to be essential for alveolar repair after damage from viruses or chemical agents.

             Amongst, the important roles of the lungs, one can cite: (i) supply oxygen, (ii) remove wastes and toxins, and (iii) defend against hostile intruders. The lungs have three dozen distinct types of cells. Some of these cells scavenge foreign matter. Others have cilia that sweep the mucous membranes lining the smallest air passages. Some cells act on blood pressure control, while others spot infection invaders.

 anatomy of lungs            

      The respiratory system is susceptible to a number of diseases, and the lungs are prone to a wide range of disorders caused by genetic factors, infection and pollutants in the air. The most common problems of the respiratory system are:

  • Asthma
  • Bronchiolitis
  • Chronic obstructive pulmonary disease (COPD)
  • Common cold
  • Cough
  • Cystic fibrosis (CF)
  • Lung cancer
  • Pneumonia
  • Pulmonary hypertension

PRINCIPAL MECHANISMS OF RESPIRATORY DEPOSITION

            The deposition of inhaled particles in the different regions of the respiratory system is very complex, and depends on many factors. Some of the factors influencing respiratory deposition include:

  • Breathing rate
  • Mouth or nose breathing
  • Lung volume
  • Respiration volume
  • Health of the individual
  • Bifurcations in the airways result in a constantly changing hydrodynamic flow field.

Depending on the particle size, airflow, and location in the respiratory system, particle deposition occurs via on of the following principal mechanisms:

Impaction

         Each time the airflow changes due to a bifurcation in the airways, the suspended particles tend to travel along their original path due to inertia and may impact on an airway surface. This mechanism is highly dependent on aerodynamic diameter, since the stopping distance for very small particles is quite low. Impaction occurs mostly in the case of larger particles that are very close to airway walls, near the first airway bifurcations. Therefore, deposition by impaction is greatest in the bronchial region. Impaction accounts for the majority of particle deposition on a mass basis.

 Sedimentation

           Sedimentation is the settling out of particles in the smaller airways of the bronchioles and alveoli, where the air flow is low and airway dimensions are small. The rate of sedimentation is dependent on the terminal settling velocity of the particles, so sedimentation plays a greater role in the deposition of particles with larger aerodynamic diameters. Hygroscopic particles may grow in size as they pass through the warm, humid air passages, thus increasing the probability of deposition by sedimentation.

 Interception

            Interception occurs when a particle contacts an airway surface due to its physical size or shape. Unlike impaction, particles that are deposited by interception do not deviate from their air streamlines. Interception is most likely to occur in small airways or when the air streamline is close to an airway wall. Interception is most significant for fibers, which easily contact airway surfaces do to their length. Furthermore, fibers have small aerodynamic diameters relative to their size, so they can often reach the smallest airways.

 

 

Diffusion

Diffusion is the primary mechanism of deposition for particles less than 0.5 microns in diameter and is governed by geometric rather than aerodynamic size. Diffusion is the net transport of particles from a region of high concentration to a region of lower concentration due to Brownian motion. Brownian motion is the random wiggling motion of a particle due to the constant bombardment of air molecules. Diffusional deposition occurs mostly when the particles have just entered the nasopharynx, and is also most likely to occur in the smaller airways of the pulmonary (alveolar) region, where air flow is low.

 

 Absorption – bioavailability of drugs

Although inhaled drugs have been used for over 50 years to treat airway disease and are in development or being considered for the treatment of many other lung diseases, insulin is at present time the only one representative inhaled drug on the market for systemic disease. Exubera® (insulin human [rDNA origin] inhalation powder is the first diabetes treatment which can be inhaled. Exubera® helps control high blood sugar, works in adults with type 1 diabetes and with type 2 diabetes as well This therapeutic success has lead a number of other companies to investigate and to advance clinical trials as inhaled formulations for systemic applications with a variety of large molecules (leuprolide, a luteinizing hormone-releasing hormone (LHRH) analogue, …). Recent advances in the development of particle technologies and devices now make it possible to formulate, stabilize, and accurately deliver almost any drug to the lungs.

             The pulmonary membrane is naturally permeable to small molecule drugs and to many therapeutic peptides and proteins. The epithelium of the lung, the significant barrier to absorption of inhaled drugs, is thick (50–60 μm) in the trachea, but diminishes in thickness to an extremely thin 0.2 μm in the alveoli. The change in cell types and morphology going from trachea, bronchi, and bronchioles to alveoli is very dramatic. The lungs are for more permeable to macromolecules than any other portal of entry into the body. Some of the most promising therapeutic agents are peptides and proteins, which could be inhaled instead of injected, thereby improving compliance .Particularly, peptides that have been chemically altered to inhibit peptidase enzymes exhibit very high bioavailabilities by the pulmonary route .Indeed, natural mammalian peptides, les than 30 amino acids (somatostatin, vaso active intestinal peptide [VIP], and glucagons), are broken down in the lung by ubiquitous peptidases and have very poor bioavailabilities. Conversely, proteins with molecular weights between 6000 and 50,000 Da are relatively resistant to most peptidases and have good bioavailabilities following inhalation. For larger proteins, the bioavailabilities and absorption mechanisms are not well completely elucidated.

ADVANTAGES OF PULMONARY DRUG DELIVERY SYSTEM

 

  1. The ability to nebulize viscous drug formulations for pulmonary delivery, thereby overcoming drug solubility issues with the ability to use lipid, water or lipid/water emulsions as drug carriers.
  2. Ability to nebulize viscous liquids into droplets in the 2-5μm range regardless of the carrier composition solubility which would allow for a wide range of drug formulation options.
  3. Increased drug delivery efficacy due to size-stable aerosol droplets with reduced

hygroscopic growth and evaporative shrinkage.

  1. Liposomal drug formulations remain stable when nebulized.
  2. Ability to nebulize protein-containing solutions.
  3. For hand held inhaler applications, drug does not need to be emulsified in liquefied nebulizing gas to achieve aerosolization.

[PPT PDF] Pharmaceutical Water System Validation – IDENTIFICATION OF MICROORGANISMS

[PPT PDF] Pharmaceutical Water System Validation - IDENTIFICATION OF MICROORGANISMS

IDENTIFICATION OF MICROORGANISMS – Pharmaceutical Water System Validation

Identifying the isolates recovered from water monitoring methods may be important in instances where specific waterborne microorganisms may be detrimental to the products or processes in which the water is used. Microorganism information such as this may also be useful when identifying the source of microbial contamination in a product or process. Often a limited group of microorganisms is routinely recovered from a water system. After repeated recovery and characterization, an experienced microbiologist may become proficient at their identification based on only a few recognizable traits such as colonial morphology and staining characteristics. This may allow for a reduction in the number of identifications to representative colony types, or, with proper analyst qualification, may even allow testing short cuts to be taken for these microbial identifications.

ALERT AND ACTION LEVELS AND SPECIFICATIONS

Though the use of alert and action levels is most often associated with microbial data, they can be associated with any attribute. In pharmaceutical water systems, almost every quality attribute, other than microbial quality, can be very rapidly determined with near-real time results. These short-delay data can give immediate system performance feedback, serving as ongoing process control indicators. However, because some attributes may not continuously be monitored or have a long delay in data availability (like microbial monitoring data), properly established Alert and Action Levels can serve as an early warning or indication of a potentially approaching quality shift occurring between or at the next periodic monitoring. In a validated water system, process controls should yield relatively constant and more than adequate values for these monitored attributes such that their Alert and Action Levels are infrequently broached.

As process control indicators, alert and action levels are designed to allow remedial action to occur that will prevent a system from deviating completely out of control and producing water unfit for its intended use. This “intended use” minimum quality is sometimes referred to as a “specification” or “limit”. In the opening paragraphs of this chapter, rationale was presented for no microbial specifications being included within the body of the bulk water (Purified Water and Water for Injection) monographs. This does not mean that the user should not have microbial specifications for these waters. To the contrary, in most situations such specifications should be established by the user. The microbial specification should reflect the maximum microbial level at which the water is still fit for use without compromising the quality needs of the process or product where the water is used. Because water from a given system may have many uses, the most stringent of these uses should be used to establish this specification.

Where appropriate, a microbial specification could be qualitative as well as quantitative. In other words, the number of total microorganisms may be as important as the number of a specific microorganism or even the absence of a specific microorganism. Microorganisms that are known to be problematic could include opportunistic or overt pathogens, nonpathogenic indicators of potentially undetected pathogens, or microorganisms known to compromise a process or product, such as by being resistant to a preservative or able to proliferate in or degrade a product. These microorganisms comprise an often ill-defined group referred to as “objectionable microorganisms”. Because objectionable is a term relative to the water’s use, the list of microorganisms in such a group should be tailored to those species with the potential to be present and problematic. Their negative impact is most often demonstrated when they are present in high numbers, but depending on the species, an allowable level may exist, below which they may not be considered objectionable.

[PPT PDF] Pharmaceutical Water System Validation – IDENTIFICATION OF MICROORGANISMS IDENTIFICATION OF MICROORGANISMS – Pharmaceutical warer system ppt [PPT PDF] Pharmaceutical Water System Validation - IDENTIFICATION OF MICROORGANISMS

As stated above, alert and action levels for a given process control attribute are used to help maintain system control and avoid exceeding the pass/fail specification for that attribute. Alert and action levels may be both quantitative and qualitative. They may involve levels of total microbial counts or recoveries of specific microorganisms. Alert levels are events or levels that, when they occur or are exceeded, indicate that a process may have drifted from its normal operating condition. Alert level excursions constitute a warning and do not necessarily require a corrective action. However, alert level excursions usually lead to the alerting of personnel involved in water system operation as well as QA. Alert level excursions may also lead to additional monitoring with more intense scrutiny of resulting and neighboring data as well as other process indicators. Action levels are events or higher levels that, when they occur or are exceeded, indicate that a process is probably drifting from its normal operating range. Examples of kinds of action level “events” include exceeding alert levels repeatedly; or in multiple simultaneous locations, a single occurrence of exceeding a higher microbial level; or the individual or repeated recovery of specific objectionable microorganisms. Exceeding an action level should lead to immediate notification of both QA and personnel involved in water system operations so that corrective actions can immediately be taken to bring the process back into its normal operating range. Such remedial actions should also include efforts to understand and eliminate or at least reduce the incidence of a future occurrence. A root cause investigation may be necessary to devise an effective preventative action strategy. Depending on the nature of the action level excursion, it may also be necessary to evaluate its impact on the water uses during that time. Impact evaluations may include delineation of affected batches and additional or more extensive product testing. It may also involve experimental product challenges.

Alert and action levels should be derived from an evaluation of historic monitoring data called a trend analysis. Other guidelines on approaches that may be used, ranging from “inspectional”to statistical evaluation of the historical data have been published. The ultimate goal is to understand the normal variability of the data during what is considered a typical operational period. Then, trigger points or levels can be established that will signal when future data may be approaching (alert level) or exceeding (action level) the boundaries of that “normal variability”. Such alert and action levels are based on the control capability of the system as it was being maintained and controlled during that historic period of typical control.

In new water systems where there is very limited or no historic data from which to derive data trends, it is common to simply establish initial alert and action levels based on a combination of equipment design capabilities but below the process and product specifications where water is used. It is also common, especially for ambient water systems, to microbiologically “mature” over the first year of use. By the end of this period, a relatively steady state microbial population (microorganism types and levels) will have been allowed or promoted to develop as a result of the collective effects of routine system maintenance and operation, including the frequency of unit operation rebeddings, backwashings, regenerations, and sanitizations. This microbial population will typically be higher than was seen when the water system was new, so it should be expected that the data trends (and the resulting alert and action levels) will increase over this “maturation” period and eventually level off.

Pharmaceutical water System

A water system should be designed so that performance-based alert and action levels are well below water specifications. With poorly designed or maintained water systems, the system owner may find that initial new system microbial levels were acceptable for the water uses and specifications, but the mature levels are not. This is a serious situation, which if not correctable with more frequent system maintenance and sanitization, may require expensive water system renovation or even replacement. Therefore, it cannot be overemphasized that water systems should be designed for ease of microbial control, so that when monitored against alert and action levels, and maintained accordingly, the water continuously meets all applicable specifications.

An action level should not be established at a level equivalent to the specification. This leaves no room for remedial system maintenance that could avoid a specification excursion. Exceeding a specification is a far more serious event than an action level excursion. A specification excursion may trigger an extensive finished product impact investigation, substantial remedial actions within the water system that may include a complete shutdown, and possibly even product rejection.

Another scenario to be avoided is the establishment of an arbitrarily high and usually nonperformance based action level. Such unrealistic action levels deprive users of meaningful indicator values that could trigger remedial system maintenance. Unrealistically high action levels allow systems to grow well out of control before action is taken, when their intent should be to catch a system imbalance before it goes wildly out of control.

Because alert and action levels should be based on actual system performance, and the system performance data are generated by a given test method, it follows that those alert and action levels should be valid only for test results generated by the same test method. It is invalid to apply alert and action level criteria to test results generated by a different test method. The two test methods may not equivalently recover microorganisms from the same water samples. Similarly invalid is the use of trend data to derive alert and action levels for one water system, but applying those alert and action levels to a different water system. Alert and action levels are water system and test method specific.

Nevertheless, there are certain maximum microbial levels above which action levels should never be established. Water systems with these levels should unarguably be considered out of control. Using the microbial enumeration methodologies suggested above, generally considered maximum action levels are 100 cfu per mL for Purified Water and 10 cfu per 100 mL for Water for Injection. However, if a given water system controls microorganisms much more tightly than these levels, appropriate alert and action levels should be established from these tighter control levels so that they can truly indicate when water systems may be starting to trend out of control. These in-process microbial control parameters should be established well below the user-defined microbial specifications that delineate the water’s fitness for use.

Special consideration is needed for establishing maximum microbial action levels for Drinking Water because the water is often delivered to the facility in a condition over which the user has little control. High microbial levels in Drinking Water may be indicative of a municipal water system upset, broken water main, or inadequate disinfection, and therefore, potential contamination with objectionable microorganisms. Using the suggested microbial enumeration methodology, a reasonable maximum action level for Drinking Water is 500 cfu per mL. Considering the potential concern for objectionable microorganisms raised by such high microbial levels in the feedwater, informing the municipality of the problem so they may begin corrective actions should be an immediate first step. In-house remedial actions may or may not also be needed, but could include performing additional coliform testing on the incoming water and pretreating the water with either additional chlorination or UV light irradiation or filtration or a combination of approaches.

Source : USP

Expert Committee : (PW05) Pharmaceutical Waters 05

USP29–NF24 Page 3056

Pharmacopeial Forum : Volume No. 30(5) Page 1744

Pharmaceutical Water System Ppt,

Pharmaceutical Water Systems,

Purified Water Specification As Per Usp,

Pharmaceutical Water System Design Operation And Validation Pdf,

pharmaceutical water system design operation and validation,

pharmaceutical water system ppt – What is Pharmaceutical water,

purified water & Water for Injection SOP as per usp,

Pharmaceutical Water Systems: Storage & Distribution Systems,

pharmaceutical water system : Inspection of Pharmaceutical water systems,

pharmaceutical water Production : Water purification systems,

Pharmaceutical Water Systems: Types: Water quality specifications,

Pharmaceutical Water System: principles for pharmaceutical water systems