The 8 references in paper S. Kuleshova I., С. Кулешова И. (2018) “Перенос (трансфер) методик, параметры валидации/верификации // Transfer of methods, and parameters of validation/verification” / spz:neicon:vedomostincesmp:y:2017:i:2:p:77-80

1
National Standard of the Russian Federation GOST 52249–2009 «Rules for the production and quality control of medicines» (in Russian).
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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).
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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).
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4
World Health Organization WHO Technical Report Series, ¹ 961, 2011. Annex 7. WHO guidelines on transfer of technology in pharmaceutical manufacturing.
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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.
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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.
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7
Monograph 1224. Transfer of analytical procedures. United States Pharmacopaeia. USP 39-NF34, 2016.
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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. AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health
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