[Doc PDF PPT ] Adenosine: Pharmacology notes B pharm M pharmacy Study Material

July 26, 2020October 25, 2017 by Renee

Adenosine Pharmacology notes for B M Pharmacy students

Pharmacology noted for B pharmacy and M Pharmacy students is readily available in our site www.pharmawiki.in/ [Doc PDF PPT ] Adenosine: Pharmacology notes B pharm M pharmacy Study Material is here below. Have a look at it and study it.

Adenosine is a purine nucleoside that regulates many physiological functions which includes respiratory regulation, neural function ,platelet aggregation, hormonal action , lymphocyte differentiation, vascular tone, negative chronotropic and dromotropic effect on heart , also mediates inhibition of neurotransmitter release and lipolysis . These physiological function have been largely revised.(1),(2)

These functions are mediated through different adenosine receptor. There are four subtypes of AR-A1,A2A-AR,A2B-AR,A3-AR each of these receptors has distinct tissue distribution and effector coupling. They belong to super family of G-protein coupled receptors (3).among these receptors A1,A3AR1 are closely related based on their sequence similarity while A2A,A2B AR also similarly related. A1 and A3 are primarly couple to G(subi) –family of G-protein.A2A and A2B are mostly coupled to GS like G- protein. Each of these receptors plays an essential role in responding to adenosine in central nervous system(4) ,regulating pain (5) . cerebral blood flow(6). Basal gangalia function (7) respiration (8) and sleep (9.) thus these receptors can be therapeutic targets for several diseases. Development of more selective agonists and antagonists for adenosine receptor subtype provide aclass of therapeutics for treatment of numerous human diseases such as apain (10). parkinsons disease (11) asthma(12) huntingtons disease(13).A search for new leads acting on specific adenosine acting on specific adenosine receptors may provide a key for novel therapeutics

Structure of A2A AR

A2A-AR subtype is linked to and G(S) and G(OLF) protein and up on activation the intracellular levels of Camp are increased . the expression A2A AR expression is higest in brain, .spleen,thymus,leucocyte and blood platelets and intermediate in heart lungs and blood vessel.(14)(15)..Crystal structure of A2A AR was determined in 2008,physiological functions A2A AR are regulation of sensori motors integration in basal ganglia., inhibition of platelet aggregation and polymorpho nuclear leucocytes, vasodilation protection against ischemic damage, stimuation of sensory nerve activity . (17) these wide range of functions implies their significant role in the body and use of chemical moieties to alter these function in disease state (may be agonists or antagonists).

A2A AR Adenosine antagonists:

A2A AR antagonist have their role in parkinsons disease, (18) keep regulations (19) controlling alcohol abuse (20) invivo receptor imaging (21) there can also be used an anti depressant drug. (22) A2 AR agonists can be a treatment for ischemic renal injure (23) paraoxysmal supro ventricular tachycardia. They can be used as vasodilators (24) antithrombic agent (25) antinflamatory (26) . they can also be used in treatment of asthma( 27), arthritis(28) sepsis (29) inflamatory bowel disease (30) and reduced skin pressure ulcer formation (26) and accelerator wound healing,(31)

In view of the role of A2A AR in these diseases afurther study in to the subject may reveal beneficial (facts) information for the treatment of such dieases. These receptors became agood targeting strategy to bring out novel therapeutics for effective treatment of dieases.

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Pharmacology study material ADENOSINE Article REFRENCES:

(1) K. A. Jacoboson, Z.G.Gao, Adenosine receptors as therapeutic targets Nal.Rev., Drug Discovery 5(2006) 247-264

(2)M.P.Abbracchio, G.BUrnstock, A.verkhasatsky, H. Zimmermann, purinergic signalling in nervous system an over view ,Trends Neurosci. 32 (2009) 19-29

(3)B.B. Fredholm, G.Arsian, L.Halldner, B.kull, G.Schutte, W.Wasserman, structure and function of adenosine receptors and their genes , Naunyn – Schmiedebergs Arch.pnaarmacol.362 (2006) 19-29

(4)(a) . T.V Dunwiddie, S.A .Masina Annu . Rev.Neurosci 24,31(2001)

(b). K.A.Jacobson, Z.G.Gao , Nat .Rev Drug Discover.5,247 (2006)

(5) J.sawynok,x.J.Liv,Drog Neurobio . 69,313 (2003)
(6) Y.Shietal, J.Cereb Blood Flow Method . 28,111 (2008)

(7) M.A.Schwarzchild , L.Agnati, K. Fure, J. Fichsn, M.M orelli , Trends Neurobiol 29. 647 (2006)

(8) S.Lahiri, CH.Nitchell.D.Reigade , A.Roy , N.s.chemiack , Respir. Physiol. Nenrobiol. 157 ,123 (2007)

(9) R.Basheer,R.E.Strecker,MM.Thatkar,R.W.M.Carley Prog. Neurobiol.73,379 (2009)

(10)J,Sawynok,X.J.Liu. Prpg.Neurobio.69,313

(11)A.H.Schapira.et.al, Nat.Rev.Drug.Discor.5,845 (2006)
(12)A. Brow, D.Spina, C.p.page, Br.J.Pharmacol.153,(suppli),5446(2008)

(13)D.Blum, R.Hourez, M.C.Galar, P.Popoli,S.N.Schiftmann, Lancet Neurol.2,366(2003)

(14)F.Meng, G.X.Xic, D.Chalmeri, C.Margan,S.J.Watson,Jr.,H.Akil,Cloning and expression of the A2a receptors from guinea pig brain Neuro chem 66(1996) 613-621

(15)R.A.Deter freud,M.Maccollin,J.Gusella,J.S.Flink Characterization and expression of the human A2a adenosine receptors gene, Neuro chem. 66(1996)362-368.

(16)Veli-Pekka Jaakola, Mark.T.Grifftin,Micheal, A.Hanson, Vadim cherezov , ellen y.t chien, J.Robert lane ,Adlioan, P.L.Jzerman, Raymond c.sterenes, the 2.6 Angstroun Crystal structure of a human A2a Adenosine receptor Bound to an Antagonist

(17)B.B.Fredholm, Adenosine, an endogenous distress signal, modulates tissue damage and repair not cell death and differentiation (2007) 14, 1315-1323

(18)Michael A .Schwarzschild, Luigi Agnati, Kjell Fuxe ,Jiang – fanchen and micaela morelli, Targetting Adenosine A2a receptors in parkinsons disease Trends in neurosciences Vol.29 No.11

(19) Satoh, S., Matsumura, H. & Hayaishi, O. Involvement of adenosine A2A receptor in sleep promotion. Eur. J. Pharmacol. 351, 155–162 (1998

(20) Yao, L. et al. dimers mediate synergy of dopamine D2 and adenosine A2 receptor-stimulated PKA signalling and regulate ethanol consumption. Cell 109, 733–743 (2002).

(21) Moresco, R. M. et al. In vivo imaging of adenosine A2A receptors in rat and primate brain using [11C]SCH442416. Eur. J. Nucl. Med. Mol. Imaging 32,405–413 (2005).

(22) El Yacoubi, M. et al. Absence of the adenosine A2A receptor or its chronic blockade decrease ethanol withdrawal-induced seizures in mice. Neuropharmacology 40, 424–432 (2001).

(23) Okusa, M. D. et al. A2A adenosine receptor-mediated inhibition of renal injury and neutrophil adhesion. Am.J. Physiol. Renal Physiol. 279, F809–F818 (2000).

(24) Fredholm, B. B., IJzerman, A. P., Jacobson, K. A., Klotz, K. N. & Linden, J. International Union of Pharmacology. XXV. Nomenclature and classification of adenosine receptors. Pharmacol. Rev. 53,527–552 (2001).

(25) Varani, K. et al. Dose and time effects of caffeine intake on human platelet adenosine A2A receptors:functional and biochemical aspects. Circulation 102,285–289 (2000)

(26) Peirce, S. M., Skalak, T. C., Rieger, J. M.,Macdonald, T. L. & Linden, J. Selective A2A adenosine receptor activation reduces skin pressure ulcer formation and inflammation. Am. J. Physiol. Heart Circ. Physiol. 281, H67–H74 (2001).

(27) Fozard, J. R., Ellis, K. M., Villela Dantas, M. F., Tigani, B. & Mazzoni, L. Effects of CGS 21680, a selective adenosine A2A receptor agonist, on allergic airways inflammation in the rat. Eur. J. Pharmacol. 438, 183–188 (2002).

(28) Montesinos, M. C. et al. Adenosine A2A or A3 receptors are required for inhibition of inflammation by methotrexate and its analog MX-68. Arthritis Rheum. 48, 240–247 (2003

(29) Sullivan, G. W., Fang, G., Linden, J. & Scheld, W. M. A2A adenosine receptor activation improves survival in mouse models of endotoxemia and sepsis. J. Infect. Dis. 189, 1897–1904 (2004).

(30) Odashima, M. et al. Activation of A2A adenosine receptor attenuates intestinal inflammation in animal models of inflammatory bowel disease. Gastroenterology 129, 26–33 (2005).

(31) Montesinos, M. C. et al. Wound healing is accelerated by agonists of adenosine A2 (Gs-linked) receptors. J. Exp. Med. 186, 1615–1620 (1997).

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

July 26, 2020October 23, 2017 by Renee

Indian pharmaceutical industry Overview and Analysis 2018 PDF PPT is now here ready for you to have a glance. The Indian pharmaceuticals market is the next biggest concerning quantity and thirteenth largest concerning value, according to a report by Equity Master. India is the biggest provider of generic medications internationally using all the Indian generics accounting for 20 percent of global exports concerning volume. Naturally, consolidation is now a significant feature of the Indian pharmaceutical marketplace as the business is extremely fragmented.
India enjoys a significant position in the worldwide pharmaceuticals sector. The nation also has a huge pool of engineers and scientists having the capability to steer the business forward to a much greater degree. Currently over 80 percent of these antiretroviral drugs used worldwide to fight AIDS (Acquired Immuno Deficiency Syndrome) are provided by Indian pharmaceutical companies.

Important Points:

The pharmaceutical industry in India ranks 3rd in the world terms of volume and 14th in terms of value.India’s cost of production is nearly 33 per cent lower than that of the US
Labour costs are 50–55 per cent cheaper than in Western countries. The cost of setting up a production plant in India is 40 per cent lower than in Western countries
Cost-efficiency continues to create opportunities for Indian companies in emerging markets & Africa
India has a skilled workforce as well as high managerial & technical competence in comparison to its peers in Asia
India has the 2nd largest number of USFDA-approved manufacturing plants outside the US
India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company sites, the highest number outside the US

Growing per capita sales of pharmaceuticals in India offers ample opportunities for players in this market
Per capita sales of pharmaceuticals expanded at a CAGR of 17.6 per cent to US$ 33 in 2016
Economic prosperity would improve affordability for generic drugs in the market & improve per capita sales of pharmaceuticals in India

The UN-backed Medicines Patent Pool has signed six sub-licences with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs, allowing them to make generic anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

Present Indian Pharma Industry Scenario

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period!. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). The sector is expected to generate 58,000 additional job opportunities by the year 2025. *
India’s pharmaceutical exports stood at US$ 16.4 billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).

Indian companies & Approvals:

Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017, thereby recording a year-on-year growth of 17 per cent. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.

India’s biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.89 billion).

Indian Pharma Industry Investments:

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions.

The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 14.71 billion between April 2000 and March 2017, according to data released by the Department of Industrial Policy and Promotion (DIPP).

Major investments in Indian pharmaceutical Sector:

Indian pharmaceutical firm, Eric Lifesciences Pvt Ltd, has launched its initial public offering (IPO) worth Rs 2,000 crore (US$ 311 million) in June 2017.

Indian pharmaceutical company, Cadila Healthcare Ltd, is planning to raise Rs 1,000 crore (US$ 155 million) via a qualified institutional placement (QIP) of shares shortly.

Capital International Group, a private equity fund, has acquired a three per cent stake in Intas Pharmaceuticals Ltd from ChrysCapital Llc for a consideration of US$ 107 million, thereby valuing Intas Pharma at approximatively US$ 3.5 billion.

Aurobindo Pharma Ltd, has acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG, which will require TL Biopharmaceutical to supply all the developmental data for four molecules, which will be developed, commercialised and marketed by Aurobindo Pharma

Piramal Enterprises Ltd acquired a portfolio of spasticity and pain management drugs from UK-based specialty biopharmaceutical company Mallinckrodt Pharmaceuticals, in an all-cash deal for Rs1,160 crore (US$ 171 million).
Aurobindo Pharma has bought Portugal based Generis Farmaceutica SA, a generic drug company, for EUR 135 million (US$ 144 million).

Sun Pharmaceutical Industries Ltd, India’s largest drug maker, has entered into an agreement with Switzerland-based Novartis AG, to acquire the latter’s branded cancer drug Odomzo for around US$ 175 million.
Kedaara Capital Advisors LLP, a private equity (PE) firm, plans to invest Rs 430 crore (US$ 64.5 million) to acquire a minority stake in Hyderabad-based diagnostics chain Vijaya Diagnostic Centre Pvt Ltd.
Sun Pharmaceuticals Industries Limited plans to acquire 85.1 per cent stake in Russian company Biosintez for US$ 24 million for increasing its presence in Russia through local manufacturing capability.
Abbott Laboratories, a global drug maker based in US, plans to set up an innovation and development center (I&D) in Mumbai, which will help in developing new drug formulations, new indications, dosing, packaging and other differentiated offerings for Abott’s global branded generics business.

Indian Government in Indian Pharma Sector:

The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programme, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.
The implementation of the Goods and Services Tax (GST) is expected to be a game-changer for the Indian Pharmaceuticals industry. It will lead to tax-neutral inter-state transactions between two dealers, thereby reducing the dependency on multiple states and increasing the focus on regional hubs. It is expected to result in an efficient supply chain management, which is expected to reduce its cost considerably. The cost of technology and investment is expected to reduce on account of tax credit which can be availed now on the duties levied on import of costly machinery and equipment.

Click below to view:

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Pharma Vision 2020:

Some of the initiatives taken by the government to promote the pharmaceutical sector in India are as follows:
The Government of India unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.
The government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.
Mr Ananth Kumar, Union Minister of Chemicals and Petrochemicals, has announced setting up of chemical hubs across the country, early environment clearances in existing clusters, adequate infrastructure, and establishment of a Central Institute of Chemical Engineering and Technology.
Road Ahead

Future Indian pharmaceutical market:

The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others.
Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.

Exchange Rate Used: INR 1 = US$ 0.0155 as on June 20, 2017.

Indian Pharmaceutical Industry Overview Analysis 2018 PPT}

References:

Consolidated FDI Policy, Department of Industrial Policy & Promotion (DIPP), Press Information Bureau (PIB), Media Reports, Pharmaceuticals Export Promotion Council
Note: ! – According to a study by UBM India, the Indian arm of London-based media and events company; * – According to IIHMR University, Jaipur.

Source :www.ibef.org

B. Pharmacy First Year Books List – Subject Notes Books PDF

July 26, 2020October 19, 2017 by Renee

B. Pharmacy First Year Books List

Here we are providing the list of books that are needed for the Pharmacy students and the links for downloading the books. Are you just tired in search of finding the First year Pharmacy books then you are up to the right place. We will provide you the cent percent correct information here and you can know all the information that you want here. In the first year course of the Pharmacy students, there are two semesters. A semester is a 6 months course and the year is divided into two semesters. Students will have the books and syllabus to be followed for a particular semester in the year.

Do you know What are the subjects of B.Pharma first semester? B.pharmacy first semester subjects are Pharamaceutics, Pharamaceutical inorganic chemistry,physics.computer programming mathematics and graphics,mathematics and statistics then your having four lab

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Pharmacy First Semester Books for First Year Students:

In the first semester of the Pharmacy, you will have 9 subjects of which 5 are theory oriented and the remaining 4 are for labs. Following table shows the first semester books for the students:

S.No	Subject	T	P	Credits
1	English	3 + 1	–	3
2	Remedial Mathematics/Remedial Biology	3/2 + 1	–	3/2
3	Human Anatomy & Physiology – I	3 + 1	–	3
4	Dispensing Pharmacy & Ethics	3 + 1	–	3
5	Pharmaceutical Organic Chemistry-I	3 + 1	–	3
6	English Communications Skills Lab	–	3	2
7	Remedial Biology Lab	–	2	0/1
8	Dispensing Pharmacy Lab	–	3	2
9	Pharmaceutical Organic Chemistry-I Lab	–	3	2
Total Credits				21

These are the first semester subjects for the students and the books for these subjects to be followed by the students. The prescribed textbooks are:

English:

‘Trail Blazers’ by Orient Black Swan Pvt. Ltd. Publishers

Remedial Mathematics/Remedial Biology:

Intermediate first Year mathematics
Intermediate Second year mathematics, printed and published by Telugu Academy, Himayatnagar, Hyderabad
Pharmaceutical Arithmetic’s by Mohd. Ali CBS publishers and distributor, New Delhi.
Higher Engineering Mathematics by Grewal.

Human Anatomy & Physiology – I:

Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
C.C.Chatterjee, Human Physiology.
Ross & Wilson, Anatomy-Physiology in health and illness.
Donald.C Rizzo, Fundamental of Anatomy and Physiology.

DISPENSING PHARMACY & ETHICS:

Cooper & Gunns Dispensing Pharmacy, CBS, Publ. and Distributors New Delhi.
R.M Metha, Dispensing Pharmacy.
NK Jain and GD Guptha, Modern Dispensing Pharmacy, Pharma Med Press.
Sanmathi BS and Anshu Guptha, Dispensing Pharmacy – A Practical Manual, Pharma Med Press.

PHARMACEUTICAL ORGANIC CHEMISTRY-I:

T.R. Morrison and R.N. Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

Pharmacy Second Semester Books for First Year Students:

In the second semester of the Pharmacy, you will be having 8 subjects. Of them 5 subjects are theory oriented and the remaining 3 are labs. Here the following table shows the subjects by specifying their credits too:

S.No	Subject	T	P	Credits
1	Human Anatomy & Physiology – II	3 + 1	–	3
2	Pharmacy Inorganic Chemistry	3 + 1	–	3
3	Pharmacy Organic Chemistry – II	3 + 1	–	3
4	Physical Pharmacy – I	3 + 1	–	3
5	Computer Applications & Biostatistics	3 + 1	–	3
6	Human Anatomy & Physiology Lab	–	3	2
7	Physical Pharmacy – I Lab	–	3	2
8	Computer Applications Lab	–	3	2
Total Credits				21

These are the subjects that are present in the second semester of the first year Pharmacy. The prescribed textbooks for these subjects are provided given below:

HUMAN ANATOMY & PHYSIOLOGY – II:

Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
Ross & Wilson – Anatomy & Physiology in health and illness – Anne Waugh, Allison Grant.
T.S. Ranganathan, A Text book of Human Anatomy.
Human Anatomy and Physiology. C.C Chatterjee.

PHARMACEUTICAL INORGANIC CHEMISTRY:

A.H.Beckett and J.B.Stenlake, Practical pharmaceutical chemistry, Part-I. The Athtone press, University of London, London.
Advanced Inorganic Chemistry by Satya prakash, G.D.Tuli B.PHARMACY 39
Wal Ankita, Wal, Pranay, Rai, Awani Kumar, Inorganic Pharmaceutical Chemistry, New Age International Publishers.

PHARMACEUTICAL ORGANIC CHEMISTRY-II:

T.R.Morrison and R.N.Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

PHYSICAL PHARMACY – I:

Patrick J. Sinko, Martin’s Physical Pharmacy and Pharmaceutical Sciences Fifth Edition.
C.V.S.Subramanyam, Essentials of Physical Pharmacy, Vallabh Prakashan.
E. Shotton and K. Ridgaway, Physical Pharmaceutics, Oxford University Press, London.
S. J Carter, Cooper and Gunn’s Tutorial pharmacy.
B. Pharmacy First Year Books List pdf

COMPUTER APPLICATIONS AND BIOSTATISTICS:

Computer Fundamentals, Anita Goel, Pearson.
Information Technology Workshop, 3e, G Praveen Babu, M V Narayana BS Publications.
Khan & Khan, “Fundamentals of Biostatistics”.
Pranab Kumar Banerjee, “Introduction to Biostatistics”.
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First impression is the best impression as said by elders. You need to score good marks in the first year to lead a happy and peaceful life along with success in your whole college life. Don’t hesitate to write to write us regarding any doubts we are happy to help you. Tell your friends about our website to help them grow in the carriers. there will be more distractions in the first year of your college but still you need to concentrate on your studies. Life will not be a bed of roses on the first here itself but as you to remove the thorns one by one you will see the fruitful year ahead. We wish you all the very best on on your first typing stone of success.

donot leave your concentration for anything. Hope this article about b pharmacy subjects list first year and the syllabus for the first year of B Pharma has helped you. Share your thoughts here on our Pharmawiki website.

[PDF] FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products DOC PPT

July 26, 2020October 17, 2017 by Renee

A filter integrity test is a critical unit operation commonly employed in the Pharma industry. FDA Guideline on Sterile Drug Products @ FILTER INTEGRITY TESTING is given below.

FILTER INTEGRITY TESTING

Sterilizing grade filters require testing to assure the filters are integral and fulfill their purpose. Such filter tests are called integrity tests and are performed before and after the filtration process. Sterilizing grade filtration would not be admitted to a process if the filter would not be integrity tested in the course of the process. This fact is also established in several guidelines, recommending the use of integrity testing, pre- and post-filtration. This is not only valid for liquid but also for air filters.

Examples of such guidelines are :

FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (1987):

Normally, integrity testing of the filter is performed after the filter unit is assembled and prior to use. More importantly however, such testing should be conducted after the filter is used in order to detect any filter leaks or perforations that may have occurred during filtration.

The Guide to Inspections of High Purity Water Systems, Guide to Inspections of Lyophilization of Parenterals, and also the CGMP document 212.721 Filters state the following:
The integrity of all air filters shall be verified upon installation and maintained throughout use. A written testing program adequate to monitor integrity of filters shall be established and followed. Results shall be recorded and maintained as specified in 212.83.
Solution filters shall be sterilized and installed aseptically. The integrity of solution filters shall be verified by an appropriate test, both prior to any large-volume parenteral solution filtering operation and at the conclusion of such operation before the filters are discarded. If the filter assembly fails the test at the conclusion of the filtering operation, all materials filtered through it during that filtering operation should be rejected. Rejected materials may be refiltered using filters whose integrity has been verified provided that the additional time required for refiltration does not result in a total process time that exceeds the limitations specified in 212.111. Results of each test shall be recorded and maintained as required in 212.188(a).
ISO 13408-1 First Edition, 1998-08-1, Aseptic Processing of Health Care Products, Part 1: General requirements: Section 17.11.1 Investigation, m. pre- and post-filter integrity test data, and/or filter housing assembly:
20.3.1. A validated physical integrity test of a process filter shall be conducted after use without disturbing the filter housing assembly. Filter manufacturer’s testing instructions or recommendations may be used as a basis for a validated method. Physical integrity testing of a process filter should be conducted before use where process conditions permit. ‘‘Diffusive Flow,’’ ‘‘Pressure Hold,’’ and ‘‘Bubble Point’’ are acceptable physical integrity tests.
20.3.2. The ability of the filter or housing to maintain integrity in response to sterilization and gas or liquid flow (including pressure surges and flow variations) shall be determined.
USP 23, 1995, P. 1979. Guide to Good Pharmaceutical manufacturing Practice (Orange

FDA Guide, U.K., 1983):

PDA (Parenteral Drug Association), Technical Report No. 26, Sterilizing Filtration of Liquids (March 1998):

Integrity tests, such as the diffusive flow, pressure hold, bubble point, or water intrusion tests, are non-destructive tests, which are correlated to the destructive bacteria challenge test with 107/cm2 B. diminuta. Derived from these challenge tests, specific integrity test limits are established, which are described and documented within the filter manufacturers’ literature. The limits are water-based; i.e., the integrity test correlations are performed using water as a wetting medium. If a different wetting fluid, such as a filter or membrane configuration, is used, the integrity test limits may vary. Integrity test measurements depend on the surface area of the filter, the polymer of the membrane, the wetting fluid, the pore size of the membrane, and the gas used to perform the test.

Wetting fluids may have different surface tensions, which can depress or elevate the bubble point pressure. The use of different test gases may elevate the diffusive gas flow. Therefore, appropriate filter validation has to be established to determine the appropriate integrity test limits for the individual process. Bubble Point Test Microporous membranes will fill their pores with wetting fluids by imbibing that fluid in accordance with the laws of capillary rise. The retained fluid can be forced from the filter pores by air pressure applied

from the upstream side. The pressure is increased gradually in increments. At a certain pressure level, liquid will be forced first from the set of largest pores, in keeping with the inverse relationship of the applied air pressure P and the diameter of the pore, d, described in the bubble point equation:

where g is the surface tension of the fluid, y is the wetting angle, P is the upstream pressure at which the largest pore will be freed of liquid, and d is the diameter of the largest pore.

When the wetting fluid is expelled from the largest pore, a bulk gas flow will be detected on the downstream side of the filter system (Fig. 7). The bubble point measurement determines the pore size of the filter membrane, i.e., the larger the pore the lower the bubble point pressure. Therefore, filter manufacturers specify the bubble point limits as the minimum allowable bubble point. During an integrity test, the bubble point test has to exceed the set minimum bubble point.

Manual bubble point test set up

1.Diffusion Test

A completely wetted filter membrane provides a liquid layer across which, when a differential pressure is applied, the diffusive airflow occurs in accordance with Fick’s law of diffusion. This pressure is called test pressure and commonly specified at 80% of the bubble point pressure. In an experimental elucidation of the factors involved in the process, Reti simplified the integrated form of Fick’s law to read as follows:

where N is the permeation rate (moles of gas per unit time), D is the diffusivity of the gas in the liquid, H is the solubility coefficient of the gas, L is the thickness of liquid in the membrane (equal to the membrane thickness if the membrane pores are completely filled

with liquid), P (p1 _ p2) is the differential pressure, and r is the void volume of the membrane, its membrane porosity, commonly around 80%. The size of pores only enter indirectly into the equation; in their combination, they comprise L, the thickness of the liquid layer, the membrane being some 80% porous. The critical measurement of a flaw is the thickness of the liquid layer. Therefore, a flaw or an oversized pore would be measured by the thinning of the liquid layer due to the elevated test pressure on the upstream side. The pore or defect may not be large enough that the bubble point comes into effect, but the

test pressure thins the liquid layer enough to result into an elevated gas flow. Therefore, filter manufacturers specify the diffusive flow integrity test limits as maximum allowable diffusion value. The larger the flaw or a combination of flaw, the higher the diffusive flow.

Pressure Hold Test:

The pressure hold test is a variant of the diffusive airflow test. The test set-up is arranged as in the diffusion test except that when the stipulated applied pressure is reached, the pressure source is valved off. The decay of pressure within the holder is then observed as a function of time, using a precision pressure gauge or pressure transducer.

The decrease in pressure can come from two sources:

1) the diffusive loss across the wetted filter. Because the upstream side pressure in the holder is constant, it decreases progressively as all the while diffusion takes place through the wetted membrane and

2) the source of pressure decay could be a leak of the filter system set-up. An important influence on the measurement of the pressure hold test is the upstream air volume within the filter system. This volume has to be determined first to specify the maximum allowable pressure drop value. The larger the upstream volume, the lower will the pressure drop be. The smaller the upstream volume, the larger the pressure drop. This also means an increase in the sensitivity of the test, and also an increase of temperature influences, if changes occur. Filter manufacturers specify maximum allowable pressure drop values.

2.Water Intrusion Test:

The water intrusion test is used for hydrophobic ventand air membrane filters only. The upstream side of the hydrophobic filter cartridge housing is flooded with water. The water will not flow through the hydrophobic membrane. Air or nitrogen gas pressure is then applied to the upstream side of the filter housing above the water level to a defined test pressure. This is done by way of an automatic integrity tester. A period of pressure stabilization takes place over time frame, by the filter manufacturer’s recommendation, during which the cartridge pleats adjust their positions under imposed pressures.

After the pressure drop thus occasioned stabilizes, the test time starts, and any further pressure drop in the upstream pressurized gas volume, as measured by the automatic tester, signifies a beginning of water intrusion into the largest (hydrophobic) pores, water being incompressible. The automated integrity tester is sensitive enough to detect the pressure drop. This measured pressure drop is converted into a measured intrusion value, which is compared to a set intrusion limit, which has been correlated to the bacteria challenge test. As with the diffusive flow test, filter manufacturers specify a maximum allowable water intrusion value. Above this value, a hydrophobic membrane filter is classified as non-integral.

References for FILTER INTEGRITY TESTING:

Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
Pharmaceutical engineering; K. Sambamurthy
Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.

Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.

FILTER INTEGRITY TESTING PDF – FDA Guideline on Sterile Drug Products PDF

FILTER INTEGRITY TESTING DOC – FDA Guideline on Sterile Drug Products

FILTER INTEGRITY TESTING PPT

FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products is helpful we hope. If you have anything to this please write to us.

What is Intellectual Property? Intellectual Property Rights & Regulatory Affairs-2

July 26, 2020August 27, 2017 by Renee

What is Intellectual Property?

The inventor of a machine, the author of a book, or the writer of music somehow usually ‘own’ their work. From this ownership, certain consequences flow and you probably have been made aware of the fact that we cannot just copy or buy a copy of their works without consideration of their rights. Equally, original industrial designs of furniture, wallpaper and the like seem naturally to be owned by someone or some organization.
Each time we buy such ‘protected’ items, a part of what we pay goes back to the owner as recompense for the time, money, effort and thought they put into the creation of the work. This has resulted over the years in the development of industries such as the music industry growing worldwide and encouraging new talent to produce more and more original ideas and articles.

The following suggests some of the things that are entitled to protection as intellectual property under national intellectual property laws and / or various international treaties:

Discs

Performances
Videos
Computer games
Broadcasts
Computer programs

Designs for objects

Images
Logos
Trademarks
Integrated circuits
Inventions

Geographical indications of origin for certain types of products

Chemical formulas
Companies’ names
Perfumes
Industrial processes
Materials

The outstanding features that most types of property share are that the owner of the property is free to use it as she/he wishes, provided the use is not against the law, and to exclude others from so using that owned item of property. Now the term “intellectual property” is reserved for types of property that result from creations of the human mind, the intellect. Interestingly, the term intellectual property in the Convention Establishing the World Intellectual Property Organization, or “WIPO”, does not have a more formal definition.
The States that drafted the Convention chose to offer an inclusive list of the rights as relating to:
“Literary artistic and scientific works; performances of performing artists, phonograms, and broadcasts; inventions in
all fields of human endeavor; scientific discoveries; industrial designs; trademarks, service marks, and commercial names and designations; protection against unfair competition; and “all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”

Intellectual property is usually deals with the following:

1) Literary, artistic and scientific works
e.g. books.
Protection of this property is governed by laws concerning Copyright.
2) Performances, broadcasts e.g. concerts.
Protection of this property is governed by laws concerning Copyright’s Related Rights.
3) Inventions
e.g. a new form of jet engine. Protection of inventions is covered by laws concerning Patents.
4) Industrial designs
e.g. the shape of a soft drinks bottle.
Industrial Designs may be protected by its own specialized laws, or those of Industrial Property or Copyright.
5) Trademarks, service marks and commercial names and designations e.g. logos or names for a product with unique geographical origin, such as Champagne.
Protection is normally available under various laws. In this course the laws are covered within the Trademark module.
6) Protection against unfair competition.
e.g. false claims against a competitor or imitating a competitor with a view
to deceive the customer. This is a theme that occurs in many of the modules in this course and is in fact the subject of a separate module.

Principles:

Common to all of the areas are two principles:
• The creators of intellectual property can acquire rights as a result of their work.
• The rights to that work may be assigned or licensed to others.

Importance of Intellectual Property Rights:

Intellectual Property Rights really matter. Do you know why?The first reason is that it is both just and appropriate that the person putting in the work and effort into an intellectual creation has some benefit as a result of this endeavor. The second reason is that by giving protection to intellectual property many such endeavors are encouraged and industries based on such work can grow, as people see that such work brings financial return. Intellectual property rights may also help to extend protection to such things as the unwritten and unrecorded cultural expression of many developing countries, generally known as folklore. With such protection they may be exploited to the benefit of the country and cultures of origin.

The reason for States to enact national legislation, and to join as signatories to either (or both) regional or international treaties governing intellectual property rights include:
• to provide incentive towards various creative endeavors of the mind by offering protections;
• to give such creators official recognition;
• to create repositories of vital information;
• to facilitate the growth of both domestic industry or culture, and international trade, through the treaties offering multi-lateral protection.

Source: World Intellectual Property Organization, or “WIPO“4

INDIAN JOURNALS List to Submit Pharmacy Research Papers – 50* Science

July 26, 2020August 20, 2017 by Renee

INDIAN JOURNALS List to Submit Pharmacy Research Papers - Science

Hello Readers. Here is the Indian Journals List to Submit Pharmacy Research Papers. You can submit your original work of your M Pharmacy or PhD on these journals. You know the value of the published papers in your career. So don not neglect write your paper under the guidance of your mentors and publish your research articles. You need to send your abstract then your approval will depend on the norms of the journal you submit. This is a list you can go through and find the best related journal to publish your paper or article.

List Indian Journals List to Submit Pharmacy Research Papers

1. Business India

2. Business Today

3. Business World

4. Chemical Weekly

5. CIMS

6. CSIR News

7. Current Literature on Science of Science

8. Current Science

9. Dataquest Magazine

10. Decision

11. DESIDOC Bulletin of Information Technology

12. Digit

13. Down to Earth

14. Drug One

15. Drugs & Pharmaceuticals-Current R & D Highlights

16. Drugs & Pharmaceuticals-Industry Highlights

17. Drugs Cases

18. Economic & Political Weekly

19. Electronics For You

20. Express Pharma

21. Fortune India

22. IDMA Bulletin

23. India Today

24. Indian Drug Reviews

25. Indian Drugs

26. Indian Journal of Biochemistry & Biophysics

27. Indian Journal of Chemical Technology

28. Indian Journal of Chemistry

29. Indian Journal of Experimental Biology

30. Indian Journal of History of Science

31. Indian Journal of Microbiology

32. Indian Journal of Pharmaceutical Education

33. Indian Journal of Pharmacology

34. Indian Management

35. Industrial Products Finder

36. Journal of Chemical Sciences

37. Journal of Food Science& Technology

38. Journal of Intellectual Property Rights

39. Journal of Marketing & Communication

40. Journal of Medicinal & Aromatic Plant Science

41. Journal of Scientific & Industrial Research

42. Management Review

43. Medicinal and Aromatic Plants Abstracts

44. MIMS India

45. Nandini Chemical Journal

46. Official Journal of the Patent Office

47. Outlook

48. Paradigm

49. Pharma Buz 50. PTI Science Service

51. Punjab University Research Journal

52. Scientific American India

53. Survey

54. Swamy News

55. Udymita Samachar Patra

56. University News

57. Vikalpa

58. Vision

59. Yojana

This is a list of Indian Journals List you can go through and find the best related journal to publish your Submit Pharmacy Research paper or article.

Top Universities & Colleges of Pharmacy in India { 11 BEST }

July 26, 2020June 20, 2017 by Renee

Top Universities & Colleges of Pharmaceutical sciences in India

Top Universities & Colleges of Pharmacy in India

In general, people wish to do Engineering after the completion of their Intermediate and EAMCET examination. The interested candidates opt for Medicine. Compared to MBBS, Pharmacy is quite easy in the field of Medicine. In India, the students who had pursued a Degree or Post Graduation in Pharmacy have innumerable career openings in this field. Before joining in Pharmacy discipline, the students need to check out the best colleges in India. The students and the parents of the candidates might be confused in choosing the best Pharmacy College in India.

It is quite essential to know about the college which you join to complete your Pharmacy in India. There are several colleges that provide the best facilities to all the students in India. The students must check whether the college has all the required equipment and other vital requirements. In order to help the students in choosing the right Pharmacy College and University, we have come up with the best post. Here is a list of the best and top Universities and Pharmacy Colleges in India. Have a look!

Best Pharmacy Universities & Colleges in India

Based on the popularity and the teaching quality, each and every college got some rankings in India. Based on the rank of the college, the students can choose the best and top Pharmacy College in India. In general, the Ministry of Human Resources Development (MHRD) releases the rankings for different institutions in India. This ministry not only decides the ranking of Pharmacy colleges but also other fields including Engineering, Management and other Universities. Besides the Ministry, the National Bureau of Accreditation (NBA) gives accreditation to a college or University based on the excellence and superiority of the college. Every year, MHRD releases the India Rankings for every college in different categories. Thousands of public and private colleges and Universities take part in the ranking process and acquire a ranking. All these colleges take a position in the list of the top and best colleges in India in their respective disciplines. Usually, NBA provides rankings to a college based on different criteria that include the following:

Teaching & Faculty
Equipment and Resources for Learning
Result of Graduation
Superiority
Efficiency
Positivity
Discernment
Research

These are the different criteria based on which NBA decides the rankings of particular college in India. All the public and private institutions in India undergo this process of judgement and attain a ranking position. In this post, we have come up with a list of the best and top Universities and Colleges for Pharmacy in India. Check it out!

National Institute of Pharmaceutical Education and Research – [NIPER], MOHALI
University Institute of Pharmaceutical Sciences, Warangal
University Institute of Pharmaceutical Sciences, Chandigarh
Manipal College of Pharmaceutical Sciences, Manipal
Birla Institute of Technology, Mesra
Jamia Hamdard, New Delhi New Delhi
Poona College of Pharmacy, Pune Pune
Institute of Pharmacy, Nirma University,
Bombay College of Pharmacy, Mumbai

[PDF PPT] Biotechnology Plant Design – Biotech Laboratory DESIGN CONSTRUCTION & VALIDATION OF GMP

July 26, 2020April 14, 2017 by Renee

Biotechnology Plant Design Lab: You need to have knowledge about the different phases of process design from idea to plant understand the methodology for feasibility studies of biotechnological processes be familiar with how technology economy market and legislation interacts in a feasibility study be familiar with the work of a project group including knowledge on some common tools for project management understand the basis for commercialization of business ideas such as market valuation access to IP and financing.

Biotechnology Plant Design

This article presents an idea of the design construction and validation issues to be considered for a GMP Biotechnology Manufacturing facility. Topics to be covered include architectural considerations equipment utilities materials of construction and computerization FDA expectations for biotech manufacturer.

It will be handy if you get some short research projects Discussions of current reference articles and case studies.

You need to consider all these below topics for a Biotechnology Plant Lab Design:

Overview/Project Life Cycle/Master Plan
Bulk Plant Design from a Process/Product Perspective
Bioreactor/Downstream Equipment Design
Facilities Design Overview/Architectural Considerations
Utilities/Materials of Construction: Properties and Selection
SIP/CIP
HVAC/Sterile Piping
Containment/Safety
Instrument Controls/Software Validation
Computerization/CIM/POM
Facilities/Utilities Validation
Approaches for the smaller biotech manufacturer
Contractual considerations
Licensing
FDA perspective

Biotech Laboratory Construction

Integrated analysis of material and energy balance

The material balances and energy balances in the process analysis design project procedure environmental regulations in setting up the plant and the cost estimation.

Process plant-design development
flow sheet development
Equipment design and specifications
Computer aided design
General overall design considerations
Environemental regulations and safety
Cost Estimation – Profitability analysis of investments
The design approach – Engineering ethics in design.
Problems in material and energy balances
Computer Aided Design

Plant location – Factors involved:

procedures for plant location
preparing the layout of plants the
storage methods and the materials handling in the industry.

Selection of plant site :

Plant layout – Preparation of plant layout
Plant operation and control
Maintenance and utilities
Storage and Material Handling

Process creation – Batch versus Continuous

The configurations of the Raw material and product specification bioreactors & the design aspects of different bioreactors and its constraints.

Process specification
Fluid flow and mixing
Problems in the fluid flow and mixing
Calculation of impellar diameter
Calculation of impellar speed and power

Process Design – Types of process design:

Process flow diagrams
Problems in the design of bioreactors
Problems in the design of bioreactors
Problems in the design of bioreactors

Design of reactor systems :

Power requirement for gasand ungassed reactors
. Design of extraction equipment
Design concepts for membrane separation
Design of filtration equipments
Design of drying equipments
Estimation of capital investment
Estimation of operating cost
Uncertainty analysis

For detailed study of mentioned topics please go through:

Plant design and Economics for Chemical Engineers Max S. Peter,Klaus D.Timmerhaus et.al.,

Chemical Engineering and Plant Design Ullmann’s

Bioprocess Engineering Principles Pauline M. Doran

Biochemical engineering fundamentals James E Bailey

Bioreactor design A.H.Scragg

Process Design Case studies Scott R & Macleod

PDF Biotechnology Plant Design – Biotech Laboratory DESIGN CONSTRUCTION & VALIDATION OF GMP

PPT Biotechnology Plant Design – Biotech Laboratory DESIGN CONSTRUCTION & VALIDATION OF GMP

Validation Protocol & Report Format + Types PDF PPT

July 26, 2020February 5, 2017 by Renee

Process validation principle incorporates the understanding that the following conditions exist:

• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing.

Here are the details of Validation Protocol & Report Format + Types PDF PPT . Analytical validation seeks to demonstrate that the analytical methods yield results which permit an objective evaluation of the quality of the pharmaceutical product as specified. The person responsible for the quality control laboratory should ensure that test methods are validated. The analytical devices used for these tests should be qualified and the measuring instruments used for the qualification should be calibrated. Each new test procedure should be validated.

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

Do you know How To Write a Validation Protocol & Report?

A suggested scheme for Validation protocol and report concerning any particular process in pharmaceutics is here:

Steps for writing Validation protocol and report:

Part 1. Purpose (the validation) and prerequisites
Part 2. Presentation of the entire process and subprocesses, flow diagram, critical steps/risks
Part 3. Validation protocol, approval
Part 4. Installation qualification, drawings
Part 5. Qualification protocol/report

5.1 Subprocess 1

5.1.1 Purpose

5.1.2 Methods/procedures

list of manufacturing methods, SOPs, and written procedures, as applicable

5.1.3 Sampling and testing procedures

Acceptance criteria (detailed description of, or reference to, established procedures, as described in pharmacopoeias)

5.1.4 Reporting

5.1.4.1 Calibration

Calibration of test equipment used in the production process

5.1.4.2 Test data (raw data)

5.1.4.3 Results (summary)
5.1.5 Approval and requalification procedure
5.2 Subprocess 2 (same as for Subprocess 1)

5.n Subprocess

Part 6. Product characteristics, test data from validation batches

Part 7. Evaluation

Evaluation including comparison with the acceptance criteria and recommendations (including frequency of revalidation/requalification)

Part 8. Certification (approval)

Part 9.Abbreviated version of the validation report

If applicable, preparation of an abbreviated version of the validation report for external use, for example by the regulatory authority

The validation protocol and report may also include copies of the product stability report or a summary of it, validation documentation on cleaning, and analytical methods.

Types of process validation:

Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation (repeated validation).

prospective
concurrent
retrospective
revalidation

Type 1 – Prospective validation

Prospective validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps: these are then evaluated on the basis of past experience to determine whether they might lead to critical situations.

Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. The trials are then performed and evaluated, and an overall assessment is made. If, at the end, the results are acceptable, the process is satisfactory. Unsatisfactory processes must be modified and improved until a validation exercise proves them to be satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale, e.g. in the preparation of injectable products.

Type 2 -Concurrent validation

Concurrent validation is carried out during normal production. This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process. The first three production-scale batches must be monitored as comprehensively as possible.1The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring.

1 This careful monitoring of the first three production batches is sometimes regarded as prospective validation.
Concurrent validation together with a trend analysis including stability should be carried out to an appropriate extent throughout the life of the product.

Process validation template Types format PDF

Type 3 -Retrospective validation

Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged; such experience and the results of in-process and final control tests are then evaluated. Recorded difficulties and failures in production are analysed to determine the limits of process parameters. A trend analysis may be conducted to determine the extent to which the process parameters are within the permissible range.

Retrospective validation is obviously not a quality assurance measure in itself, and should never be applied to new processes or products. It may be considered in special circumstances only, e.g. when validation requirements are first introduced in a company. Retrospective validation may then be useful in establishing the priorities for the validation programme. If the results of a retrospective validation are positive, this indicates that the process is not in need of immediate attention and may be validated in accordance with the normal schedule. For tablets which have been compressed under individual pressure-sensitive cells, and with qualified equipment, retrospective validation is the most comprehensive test of the overall manufacturing process of this dosage form. On the other hand, it should not be applied in the manufacture of sterile products.

Type 4 -Revalidation

Revalidation is needed to ensure that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.

Revalidation may be divided into two broad categories:

• Revalidation after any change having a bearing on product quality.
• Periodic revalidation carried out at scheduled intervals.
Revalidation after changes. Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure having a bearing on the established product performance characteristics. Such changes may include those in starting material, packaging material, manufacturing processes, equipment, in-process controls, manufacturing areas, or support systems (water, steam, etc.). Every such change requested should be reviewed by a qualified validation group, which will decide whether it is significant enough to justify revalidation and, if so, its extent.

Re-validation after changes may be based on the performance of the same tests and activities as those used during the original validation, including tests on sub-processes and on the equipment concerned. Some typical changes which require revalidation include the following:

• Changes in the starting material(s). Changes in the physical properties, such as density, viscosity, particle size distribution, and crystal type and modification, of the active ingredients or excipients may affect the mechanical properties of the material; as a consequence, they may adversely affect the process or the product.

• Changes in the packaging material, e.g. replacing plastics by glass, may require changes in the packaging procedure and therefore affect product stability.

• Changes in the process, e.g. changes in mixing time, drying temperature and cooling regime, may affect subsequent process steps and product quality.

Process validation template Types format PPT Power Point

• Changes in equipment, including measuring instruments, may affect both the process and the product; repair and maintenance work, such as the replacement of major equipment components, may affect the process.

• Changes in the production area and support system, e.g. the rearrangement of manufacturing areas and/or support systems, may result in changes in the process. The repair and maintenance of support systems, such as ventilation, may change the environmental conditions and, as a consequence, revalidation/requalification may be necessary, mainly in the manufacture of sterile products.

• Unexpected changes and deviations may be observed during self-inspection or audit, or during the continuous trend analysis of process data.
Periodic revalidation. It is well known that process changes may occur gradually even if experienced operators work correctly according to established methods. Similarly, equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.

The decision to introduce periodic revalidation should be based essentially on a review of historical data, i.e. data generated during in-process and finished product testing after the latest validation, aimed at verifying that the process is under control. During the review of such historical data, any trend in the data collected should be evaluated.

In some processes, such as sterilization, additional process testing is required to complement the historical data. The degree of testing required will be apparent from the original validation.

HPLC Detectors – Types Comparison Principles {PDF PPT}*

July 26, 2020January 29, 2017 by Renee

Here in this article we provide HPLC Detectors – Types Comparison Principles {PDF PPT}*.Different types of HPLC Detectors are given here for you for educational purpose. The HPLC detectors are used to detect the solute present in the eluent comes from the HPLC column. Different HPLC detectors are used in analysis of different types of samples to detect solute having different chemical nature.

HPLC Detectors – Types:

1. Ultraviolet/visible spectroscopic detectors{UV Detector/ VIS Detector}

– Fixed Wavelength Detector
– Variable Wavelength Detector
– Diode array Detector
PDA Detector
2. Refractive-Index Detector

-Deflection Detector
-Refractive Detector (Fresnel refractometer)
3. Evaporative Light Scattering Detector
4. Multi-Angle Light Scattering Detector
5. Mass Spectrometer
6. Conductivity Detector
7. Fluorescence Detector
8. Chemiluminescence Detector
9. Optical Rotation Detector
10. Electro Chemical Detector

HPLC Detectors Comparision – Best Detectors properties:

Regardless of the principle of operation, an ideal LC detector should have the following properties:
Low drift and noise level (particularly crucial in trace analysis).
High sensitivity.
Fast response.
Wide linear dynamic range (this simplifies quantitation).
Low dead volume (minimal peak broadening).
Cell design which eliminates remixing of the separated bands.
Insensitivity to changes in type of solvent, flow rate, and temperature.
Operational simplicity and reliability.
It should be tuneable so that detection can be optimized for different compounds.
It should be non-destructive.

HPLC Detectors Uses:

Most common Detectors of HPLC:

Refractive index
UV/Vis
Fixed wavelength (no longer used)
Variable wavelength
Diode array
Fluorescence

Less common, but important Detectors:

Conductivity
Mass-spectrometric (LC/MS)
Evaporative light scattering

HPLC Detectors – Types Comparison Principles {PDF PPT}*:

Variable-wavelength UV detectors:

Detectors which allow the selection of the operating wavelength called variable wavelength detectors and they are are particularly useful in three cases:
offer best sensitivity for any absorptive component by selecting an appropriate wavelength;
individual sample components have high absorptivity at different wavelengths and thus, operation at a single wavelength would reduce the system’s sensitivity;

Depending on the sophistication of the detector, wavelength change is done manually or programmed on a time basis into the memory of the system.

Any chemical compound could interact with the electromagnetic field. Beam of the electromagnetic radiation passed through the detector flow-cell will experience some change in its intensity due to this interaction. Measurement of this changes is the basis of the most optical HPLC detectors.
Radiation absorbance depends on the radiation wavelength and the functional groups of the chemical compound. Electromagnetic field depending on its energy (frequency) can interact with electrons causing their excitation and transfer onto the higher energetical level, or it can excite molecular bonds causing their vibration or rotation of the functional group. The intensity of the beam which energy corresponds to the possible transitions will decrease while it is passing through the flow-cell. According to the Lambert-Bear law absorbance of the radiation is proportional to the compound concentration in the cell and the length of the cell.

HPLC Detectors – Types Comparison Principles Power point {PDF PPT}

Multi-Angle Light Scattering Detector:

For the SEC analysis, MW of analyte is estimated from the calibration curve drown using a set of known standards. However, by using a MALS, MW can be determined directly without the need of calibration curve. Also MALS can provide an absolute MW of the analyte with very low detection limit.

Refractive index detectors:

These bulk property detectors are based on the change of refractive index of the eluant from the column with respect to pure mobile phase. Although they are widely used, the refractive index detectors suffer from several disadvantages – lack of high sensitivity, lack of suitability for gradient elution, and the need for strict temperature control (±0.001 °C) to operate at their highest sensitivity. A pulseless pump, or a reciprocating pump equipped with a pulse dampener, must also be employed. The effect of these limitations may to some extent be overcome by the use of differential systems in which the column eluant is compared with a reference flow of pure mobile phase. The two chief types of RI detector are as follows.

Deflection refractometer:

The deflection refractometer, which measures the deflection of a beam of monochromatic light by a double prism in which the reference and sample cells are separated by a diagonal glass divide. When both cells contain solvent of the same composition, no deflection of the light beam occurs; if, however, the composition of the column mobile phase is changed because of the presence of a solute, then the altered refractive index causes the beam to be deflected. The magnitude of this deflection is dependent on the concentration of the solute in the mobile phase.

Fresnel refractometer:

The Fresnel refractometer which measures the change in the fractions of reflected and transmitted light at a glass-liquid interface as the refractive index of the liquid changes. In this detector both the column mobile phase and a reference flow of solvent are passed through small cells on the back surface of a prism. When the two liquids are identical there is no difference between the two beams reaching the photocell, but when the mobile phase containing solute passes through the cell there is a change in the amount of light transmitted to the photocell, and a signal is produced. The smaller cell volume (about 3 ilL) in this detector makes it more suitable for high-efficiency columns but, for sensitive operation, the cell windows must be kept scrupulously clean.

HPLC Detectors – Types Comparison Principles PDF word document {PDF PPT}

Mass Spectrometer:

The analytes are detected based on their MW. The obtained information is especially useful for compound structure identification. However, its use is not limited to structure identification and can be used to quantify very low detection limit of elemental and molecular components.

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