DIFFERENT ASPECTS INVOLVED IN PROCESS VALIDATION
Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. Validation of the individualsteps of the processes is called the process validation. Process validation involves the collection and evaluation of data, from the process design stage throughout production, that establish scientific evidence that a process is capable of consistently delivering a quality drug substance. It is internationally recognized that validation is necessary in analyticallaboratories. The use of validated methods is important for an analyticallaboratory to show its qualification and competency.This new approach to process validation encompasses equipmentand utility qualification and is fully science and risk-based. Itprovides the pharmaceutical industry with the opportunity tore-think the whole concept of validation and ensure that theseactivities add real value to our businesses and to patients.It involves prospective validation, retrospective validation and concurrent validation.A life-cycle approach should be applied linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
KEYWORDS:Validation, prospective validation, concurrent validation, retrospectiveÂ validation, quality by design
2. â€œAnnex 15 to the EU Guide to Good Manufacturing Practice â€” Qualification and Validationâ€ (European Commission, Rue de la Loi, Wetstraat 200, B-1049 Brussels, Belgium, 2001).
3. Aulton M. E., pharmaceutics, the science ofdosage form design, international edition,second edition, Churchill Livingston (Elsevier),2006, 1.
4. Robert A Nash, Alfred H Wachter,Pharmaceutical Process Validation, Third Edition,volume 129, Marcel Dekker, Inc, New York, 2003,159-180
5. ICH-Q2A, Guideline for Industry: Text on Validation of AnalyticalProcedures, 1995 (http://www.fda.gov/cder/guidance/index.htm).
6. Isabel Taverniers, Marc De Loose, Erik Van Bockstaele, Trends in quality in the analyticallaboratory. II. Analytical methodvalidation and quality assuranceVol. 23, No. 8, 2004, pg no.535-550
7. ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), May 2011EMA/CHMP/ICH/425213/2011 ICH/ Committee for medicinal products for human use (CHMP), pg no- 13
8. Peter Gough â€œModern approaches to process validationâ€, journal of NSF-DBA, issue 20, US winter 2012,The Health Sciences,Training, Consultancyand Auditing Experts, pg no. 1-4. Journal of NS
9. South African guide to Good Manufacturing Practice, Medicine Control Council, Pretoria, 1996.
10. Guideline on General Principles of Process Validation, May 1987, FDA, CDRH/CDER
11. Journal of Validation Technology, Vol. 1, No. 4, August 1995
12. FDA Guide on APIs, March 1998, page 48; PICGuide, March 1999, page 32; Gold Sheet, Feb1999, 6.
13. Chaitanya kumar G, Rout RP, Ramtake S,Bhattachaiya S, Process Validation, The Indianpharmacist, Aug 2005, 14-19.
14. Kathiresan K, Kiran K, Basics of Validation-Pharmaceutical Perspective, first edition, K.K.Publishers, Chidambaram, 2005, 32-46.
15. A History of Validation in the United States A paper presented by Kenneth Chapman at the ISPE Annual Meeting, 1994 - Kemper-Masterson, Inc.
16. Computer Systems Validation for the Pharmaceutical and Medical Device Industries, Richard Chamberlain, Alaren Press 1991
17. Guideline on General Principles of Process Validation - Center for Drugs and Biologics and Center for Devices and Radiological Health, Food and Drug Administration, May 1987.
18. Code of Federal Regulations, CFR 21 - Part 210 and 211 - Food and Drug Administration - April 1990 Revision
19. GAMP 3 â€“ Good Automated Manufacturing Practices version 3.0, ISPE
20. Yubing Tang, Ph.D.â€Quality by Design Approaches to Analytical Methodsâ€ â€“FDA/CDER/ONDQA AAPS, Washington DC, October 25, 2011, 1-21.
21. Guidance for Industry, Process Validation: General Principles and Practices, U.S. Department of Health and Human Services Food and Drug Administration, CDER, CBER, CVM, Current Good Manufacturing Practices (CGMP), Revision 1, January 2001
22. Chatterjee, Wong and Rafa, Using Operational Excellence to Meet the New Process Validation Guidance, Pharmaceutical Engineering, Sept 2011.
23. Immel, B.G. (2005) A brief history ofGMPs. Regul. Compliance Newslett.,winter.
24. U.S. Department of Health and HumanServices Food and Drug Administration(2004) Pharmaceutical cGMPS for the21st Century â€“ A Risk-Based Approach:Second Progress Report and ImplementationPlan.
25. U.S. Department of Health and HumanServices Food and Drug Administration(2007) Pharmaceutical Quality for the 21stCentury: A Risk-Based Approach. http://www.fda.gov/oc/cgmp/report0507.html.
26. Juran, J.M. (1992) Juran on Quality byDesign â€“ The New Steps for PlanningQuality into Goods and Services, the FreePress.