Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics
Abstract
These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regulatory documents sections with a detailed description of subsections structure, the peculiarities of presentation of the methods for evaluation of physicochemical quality characteristics of immunobiologicals and the typical mistakes made in the process of drafting regulatory documents.
About the Authors
O. B. Ustinnikova
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
O. B. Runova
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. V. Velichko
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
References
1. Federal'nyj zakon № 61-FZ ot 12 aprelja 2010 g. «Ob obrashhenii lekarstvennyh sredstv» (in Russian).
2. State Standard GOST R ISO 5725-1-2002. Accuracy (trueness and precision) of measurement methods and results. Part 1: Basic terms and definitions. Moscow: Gosstandart Rossii; 2002. P. 24 (in Russian).
3. State Standard GOST ISO/MJeK 17025-2009. General requirements for the competence of testing and calibration laboratories. Moscow: Gosstandart Rossii; 2009 (in Russian).
4. Guideline PA/PH/OMCL (13) 113 R Evaluation and reporting of results.
5. MI 2881-2004 Rekomendacija. GSOEI. The techniques of quantitative chemical analysis. Procedures for verifying the acceptability of the results of the analysis. Moscow; 2004 (in Russian).
6. Mironov AN, ed. Manual on expertise of medicines. V. II. Moscow: Grif i K; 2013. 280 p. (in Russian).
7. The State Pharmacopoeia of Russian Federation, 12th ed., V. 1. Moscow: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation; 2008 (in Russian).
8. European Parmacopoeia 8.1 04/2014, 2.2.29 Liquid chromatography, 2.2.30 Size-exclusion chromatography, 2.2.46 Chromatographic separation techniques.
Review
For citations:
Ustinnikova O.B., Runova O.B., Velichko E.V. Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(3):8-12. (In Russ.)
Views:
718
Email this article 