Transfer of methods, and parameters of validation/verification
Abstract
The article analyses foreign and national recommendations on transfer of methods. It substantiates the need to adequately reproduce test methods that introduce a specific analytical procedure in testing laboratories - in order to be able to give a reliable assessment of the quality of substances and dosage forms. The article gives examples of a successful analytical method transfer, describes ways of transferring analytical procedures, cases when the transfer of method is not needed, and validation/verification parameters that are used to check whether the method is suitable for a particular laboratory. It also gives examples of validation parameters that are used in verification of pharmacopoeial methods, which are chosen based on the type of method and the tested parameter.
Keywords
аналитическая методика,
лекарственное средство,
перенос (трансфер) методики,
валидация,
верификация,
передающая лаборатория,
принимающая лаборатория,
параметры валидации/верификации,
analytical procedure,
medicine,
transfer of method,
validation,
verification,
sharing laboratory,
receiving laboratory,
validation/verification parameters
About the Author
S. I. Kuleshova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. National Standard of the Russian Federation GOST 52249–2009 «Rules for the production and quality control of medicines» (in Russian).
2. RMG 61 – 2010 State system for ensuring the uniformity of measurements. Accuracy, trueness and precision of quantitative chemical analysis procedures. Assessment methods. Moscow; 2010 (in Russian).
3. General monograph 1.1.0012.15. Validation of analytical procedures. State Pharmacopoeia of the Russian Federation. 13th ed. Moscow; 2015. Available from: http://femb.ru/feml (in Russian).
4. World Health Organization WHO Technical Report Series, ¹ 961, 2011. Annex 7. WHO guidelines on transfer of technology in pharmaceutical manufacturing.
5. European Directorate for the Quality of Medicines & HealthCare. PA/PH/OMCL (05) 47- DEF—OMCL Guideline on Validation of Analytical Procedures. Available from: https://goo.gl/TLBX9N.
6. Analytical Procedures and Methods. Validation for Drugs and Biologics Guidance for Industry. U. S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). July 2015. Pharmaceutical Quality/CMC. Available from: https://goo.gl/3jEAKF.
7. Monograph 1224. Transfer of analytical procedures. United States Pharmacopaeia. USP 39-NF34, 2016.
8. Scypinski S, Roberts D, Oates M, Etse J. Pharmaceutical Research and Manufacturers Association. Acceptable Analytical Practice for Analytical Method Transfer. Pharmaceutical Technology, March 2002: 84–8.
Review
For citations:
Kuleshova S.I. Transfer of methods, and parameters of validation/verification. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):77-80. (In Russ.)
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