Current problems with the standard samples of medicines in the Russian Federation

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DOI: https://doi.org/10.29296/25419218-2020-02-01
Issue: 
2
Year: 
2020

R.A. Volkova, O.V. Fadeikina, O.B. Ustinnikova, E.I. Sakanyan, V.A. Merkulov, A.A. Movsesyants, V.P. Bondarev, Yu.V. Olefir Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, 8, Petrovsky Boulevard, Moscow 127051, Russian Federation

Standard samples (SSs) for drug quality control procedures require a special approach, which is marked by biological agent (BA) control methods in general and biological control ones in particular. The list of SSs of the Research Center for Examination of Medical Products (RCEMP) currently includes 61 names for SSs. By analyzing international guidelines and recommendations and by generalizing the experience of the RCEMP in developing, certifying, and using SSs to control BA quality and to consider the Russian normal legal base of state SSs and the documents of the Eurasian Economic Union, the authors have proposed the main study areas to improve SSs, which include the elaboration of approaches to validating similar (same type) biological, methods for certifying SSs; the development of the order in which alternative approaches are applied to statistically processing test results when certifying SSs of medicines in the absence of a normal distribution of results; the formation of Russia’s requirements for the development, quality assessment, and procedure for certification of both primary and secondary SSs of a manufacturer; the development of SS requirements for qualitative (not quantitative) procedures.
Keywords: 
medicines
biological standard samples
certification
biological methods
validation
References: 
  1. Botha A. Harmonised guidance for the producers and users of reference marerials- the current status and future prospects. Collection of works. Part «Ru». III International Scientific Conference «Standard samples in measurements and technologies». Ekaterinburg, Ural'skiy nauchno-issledovatel'skiy institut metrologii, 2018; 11–2.
  2. Bremser W., Menzel W. Validation of methods for the determination of qualitative properties. Collection of works. Part «Ru». III International Scientific Conference «Standard samples in measurements and technologies». Ekaterinburg, Ural'skiy nauchno-issledovatel'skiy institut metrologii, 2018; 13.
  3. Merkulov V.А., Sakanyan Е.I., Volkova R.А. et al. Pharmacopoeial standard samples and the practice of their use in the domestic system of standardization of drugs. Khimiko-farmatsevticheskiy zhurnal, 2016; 50 (4): 40–3 (in Russian).
  4. WHO Expert Committee on biological standardization. Recommendations for the preparation and establishment of international and other biological reference standards. Technical Reports Series № 932. Annex 2. Geneva: WHO, 2004; 73–131.
  5. WHO manual for the establishment of national and other secondary standards for vaccines. WHO/IVB/11/03. 2011.
  6. Bondarev V.P., Borisevich I.V., Volkova R.А.., Fadeуkina О.V. Problems of certification of industry standard samples for quality control of immunobiological drugs. Vedomosti Nauchnogo Tsentra Ekspertizi Sredstv Meditsinskogo Primeneniya, 2013; 2: 28–32 (in Russian).
  7. Merkulov V.А., Sakanyan Е.I., Klimov V.I. et al. Modern approaches to the development of standard samples for assessing the quality of pharmaceutical substances. Khimiko-farmatsevticheskiy zhurnal, 2015; 49 (11): 54–6 (in Russian).
  8. Volkova R.А., Fadeуkina О.V. Problems of assessing the uncertainty of test methods and standard samples of immunobiological drugs. Biopreparati. Profilaktika. Diagnostika. Lechenie, 2017; 17 (1): 27–31 (in Russian).
  9. Fadeуkina О.V., Volkova R.А. Development of certification procedures for standard samples of biological drugs. Khimiko-farmatsevticheskiy zhurnal, 2017; 51(8): 44–50 (in Russian).
  10. Volkova R.А.., Fadeуkina О.V., Klimov V.I. et al. Actual issues of reference materials in the field of circulation of biological drugs. Biopreparati. Profilaktika. Diagnostika. Lechenie, 2016; 16 (4): 229–36 (in Russian).
  11. Olefir Yu.V., Volkova R.А.., Fadeуkina О.V. et al. Problems of standard samples of biological drugs. Collection of Abstracts III International Scientific Conference «Standard samples in measurements and technologies». Ekaterinburg, Ural'skiy nauchno-issledovatel'skiy institut metrologii, 2018; 148–50 (in Russian).
  12. Fadeуkina О.V., Volkova R.А. Methodological approaches to statistical processing of test results obtained during certification of standard samples for assessing the quality of biological drugs. Collection of Abstracts III International Scientific Conference «Standard samples in measurements and technologies». Ekaterinburg, Ural'skiy nauchno-issledovatel'skiy institut metrologii, 2018; 174–78 (in Russian).
  13. Decision of the Board of the Eurasian Economic Commission of July 17, 2018 № 113 «On Approval of the Guidelines for the Validation of Analytical Methods for Testing Medicines» (in Russian).
  14. Requirements for the validation of bioanalytical test methods and the analysis of the studied biological samples. (Rules for conducting bioequivalence studies of drugs. Appendix 6.) NPА EAEU 2016 (in Russian).
  15. Gaiderova L.А., Nikitina Т.N., Fadeуkina О.V. et al. Certification of the industry standard activity sample of leukocyte interferon α-type. Biopreparati. Profilaktika. Diagnostika. Lechenie, 2014; 3 (51): 40–5 (in Russian).
  16. Ustinnikova О.B., Goloshapova Е.О., Runova О.B. et al. Development of a certification procedure for a standard sample of the methionine form of interferon α-2b to confirm authenticity by peptide mapping. Meditsinskaya immunologiya, 2018; 20 (4): 543–50 (in Russian).