The history of development of Pharmacopoeia standards quality biological drugs and methods of tests in Russia

The Russian system of standardization of HP including biological medicines is based on the State Pharmacopoeia of the Russian Federation numbering more than the 250th summer history of the development. Requirements of general the farmakopoeia and the farmakopoeia of articles included in the State Pharmacopoeia of the Russian Federation are obligatory for all organizations which are engaged in the territory of the Russian Federation in production, production, quality control, storage and use of medicines. Historical development the farmakopoeia of the quality standards on biological medicines is reflected in article, starting with the first publications of articles editions (1910) and to GF Programme of the Russian Federation editions (2015) in which are provided are included in GF VI of Russia 57 OFS and 56 FS on the biological medicines allowing to provide standardization of requirements to their quality. Further enhancement and development of various directions in the immunobiology, immunobiological technologies which are based on a joint of immunology and molecular biology, and also genetic engineering and as a result of it, development of new BLP requires further development and the standardization of these HP guaranteeing their quality at all stages of lifecycle.

государственная фармакопея, иммунобиологические лекарственные препараты, биологические лекарственные препараты, биотехнологические лекарственные препараты, общая фармакопейная статья, фармакопейная статья, методы испытания, показатели качества, state pharmacopeia, immunobiological medicinal preparations, biological medicinal preparations, biotechnological medicinal preparations, general farmakopoeia article, farmakopoeia article, test methods, quality indicators

1. Federal law of the Russian Federation of 12 April 2010 № 61-FZ «On circulation of medicines» (in Russian).

2. WHO document QAS/12.512 (in Russian).

3. WHO Expert Committee on Biological Standardization. Good Manufacturing Practices for Biological Products. Technical Report Series ¹ 822. Annex 1. Geneva: WHO; 1992.

4. WHO Manual of Laboratory Methods for Potency Testing of Vaccines used in the WHO Expanded Programmå on Immunization. WHO/BLG/95.1.

5. European Pharmacopoeia. 8th ed. Available from: http//online.edqm.eu/entry.htm.

6. The United States Pharmacopeia (USP 38), 2015.

7. The State Pharmacopeia. 6th edition. Moscow; 1910 (in Russian).

8. The State Pharmacopeia. 7th edition. Moscow–Leningrad: Biological and medical literature;1937 (in Russian).

9. The State Pharmacopoeia of the USSR. 8th edition. Moscow: Medgiz; 1952 (in Russian).

10. The State Pharmacopoeia of the USSR. 9th edition. Moscow: Medgiz; 1961 (in Russian).

11. The State Pharmacopoeia of the USSR. 10th edition. Moscow: Meditsina; 1968 (in Russian).

12. The State Pharmacopoeia of the USSR. 11th edition. Issues 1, 2. Moscow: Meditsina; 1987, 1990 (in Russian).

13. The State Pharmacopoeia of the Russian Federation. 12th edition. Part 1. Moscow: NCESMP; 2007 (in Russian).

14. The State Pharmacopoeia of the Russian Federation. 13th edition. V. 1, 2, 3. 2015. Available from: http://femb.ru/feml (in Russian).

15. Editorial. Lev A. Tarasevich (to the 145 anniversary from the birthday). Biopreparaty 2013; 1(45): 4 (in Russian).

16. The Ministry of health order № 771 dated October 29, 2015 «On approval of General Pharmacopeia articles and Pharmacopeia articles». (in Russian)

17. Karyakin AV, Kargina TM, Sakanyan EI, Osipova IG, Movsesyants AA, Kudasheva EYu. Modern approaches to the development of projects of General Pharmacopeia monographs and Pharmacopeia monographs for the preparations of human blood. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2015; (3): 47–51 (in Russian).

18. Movsesyants AA, Bondarev VP, Olefir YuV, Merkulov VA, Simchuk LF. Quality Standards for immunobiological medicinal products — a new the State Pharmacopoeia of the Russian Federation. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2016; (2): 38–41 (in Russian).

19. Olefir YuV, Medunitsyn NV, Avdeeva ZhI, Soldatov AA, Movsesyants AA, Merkulov VA, Bondarev VP. A Modern biological/biotechnological medicinal products. Topical issues of development and prospects. Biopreparaty 2016; (2): 67–75 (in Russian).

20. Osipova IG, Evlashkina VF, Davydov DS, Sakanyan EI. General monograph on drugs probiotics for the State Pharmacopoeia of the Russian Federation GPH edition — first experience in the world of Pharmacopoeia practice. Mezhdunarodniy zhurnal prikladnyh i fundamentalnyh issledovaniy 2016; 6–5: 272–6 (in Russian).

21. Federal law of the Russian Federation of 12 April 2010 № 61-FZ «On circulation of medicines» (amendments to the Federal law of 22.12.2014 № 429) (in Russian).