Topical issues related to reference standards in the sphere of circulation of biological products

Pharmacopoeial analytical methods involving reference standards (RS) are used for manufacture and quality control of medicinal products, including biologicals, these RS should now to be called pharmacopoeal. The introduction of the mentioned term reflects special drug characteristics, which are regulated not by the State Union Standards but by the Russian State Pharmacopoeia in terms of quality control. Drug and RS special characteristics require the establishment of legal and methodological framework. The recommendations stated in ISO REMCO are general do not fully cover the special aspects of the certification of reference standards for each specific area. The documents of the Federal Agency for Technical Regulating and Metrology (Rosstandart) on reference standards can not be used for biological medicinal products due to their specificity as the test methods do not allow to separate systematic and random components of uncertainty of test results, as required by Rosstandart. The regulatory framework for biological RS should be developed on the basis of WHO and ICH Guidelines. The classification of drug reference standards and the list of priority documents required for the elaboration of normative and procedural framework regulating their development, certification, approval and use is considered in the article. The development of the documents for the mentioned system is exemplified by a new pattern for an RS certificate.

стандартный образец, биологические лекарственные средства, нормативно-методические документы, классификация стандартных образцов, паспорт стандартного образца, reference standard, biological products, normative and procedural documents, classification of reference standards, certificate of a reference standard

1. Federal Law of the Russian Federation, April 12, 2010, ¹ 61-FZ «On Circulation of Medicines» (in Russian).

2. Merkulov VA, Sakanyan EI, Volkova RA, Klimov VI, Shemeryankina TB, Yashkir VA. Pharmacopoeial reference standards and their implementation in the national system of standardization of medicines. Himiko-farmatsevticheskiy zhurnal 2016; 50(4): 40–3 (in Russian).

3. The State Pharmacopoeia of the USSR. 11th ed. Issue 2. Moscow: Meditsina; 1990 (in Russian).

4. The State Pharmacopoeia of the Russian Federation. 12th ed. Part 1. Moscow: NCESMP; 2008 (in Russian).

5. The State Pharmacopoeia of the Russian Federation. 13th ed. V. 2. Moscow; 2015. Available from: http://193.232.7.107/feml.

6. The State Pharmacopoeia of the Republic of Belarus. Minsk: Tsentr ekspertiz i ispytaniy v zdravoohranenii; 2009 (in Russian).

7. The State Pharmacopoeia of Ukraine. 1st ed. Suppl. 1–4. Kharkov: Nauchno-ekspertny farmakopeyny tsentr; 2012 (in Russian).

8. The State Pharmacopoeia of the Republic of Kazakhstan. V. I. Almaty: Zhibek Zholy; 2008 (in Russian).

9. British Pharmacopoeia, 2009. V. 1–4.

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

11. The International Pharmacopoeia (First and Second Supplements). 4th ed. 2011. Available from: http://apps.who.int/phint/en/p/about/.

12. United States Pharmacopeia. 35th ed. Available from: http:// www.uspnf.com/uspnf/login.

13. State Standard 8.315–97 GSI. Standard samples of structure and properties of substances and materials. The main provisions. Moscow: Izdatelstvo standartov; 2004 (in Russian).

14. State Standard Ð 8.753–2011 GSI. Standard samples of materials (substances). Fundamentals. Moscow: Standartinform; 2013 (in Russian).

15. State Standard 8.532–2002 GSI. Standard samples of structure and properties of substances and materials. Interlaboratory metrological certification. Content and procedure of works. Moscow: Izdatelstvo standartov; 2003 (in Russian).

16. State Standard Ð 8.563–2009 GSI. Techniques (methods) of measurements. Moscow: Standartinform; 2010 (in Russian).

17. State Standard Ð 8.694–2010 (ISO Guide 35:2006, MOD) GSI. Standard samples of materials (substances). General and statistical principles for determining the metrological characteristics of reference materials. Moscow: Standartinform; 2012 (in Russian).

18. Bondarev VP, Borisevich IV, Volkova RA, Fadeykina OV. Industry reference standards certification for the control of medical immunobiological preparations. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2013; (2): 28–32 (in Russian).

19. Volkova RA. Methods of control or testing procedures — the issue of metrological support of analytical methods. Spravochnik zaveduyuschego KDL 2013; (4): 4–9 (in Russian).

20. Merkulov VA, Sakanyan EI, Volkova RA, Klimov VI, Shemeryankina TB, Yashkir VA. Modern approaches to the development of standard models for assessing the quality of pharmaceutical substances. Himiko-farmatsevticheskiy zhurnal 2015; 49(11): 54–6 (in Russian).

21. WHO Expert Committee on biological standardization. Recommendations for the preparation and establishment of international and other biological reference standards. Technical Reports Series ¹ 932. Annex 2. Geneva: WHO; 2004. Ð. 73–131, 137.

22. ISO Guide 30:1992. Terms and definitions used in connection with reference material [cited 2016 Mar 14]. Available from: http:// www.iso.org/iso/catalogue_detail.htm?csnumber=21638.

23. ISO Guide 31:2001 (Released: 31:2015) Reference material — Content of certificates and labels [cited 2016 Mar 14]. Available from: http://www.en-standard.eu/iso-guide-31-reference-materialscontents-of -certificates-and-labels/.

24. ISO Guide 33:2002. Uses of certified reference materials [cited 2016 Mar 14]. Available from: http://www.en-standard.eu/iso-guide33-uses-of-certified-reference-materials/.

25. ISO Guide 34:2009. General requirements for the competence of reference material producers [cited 2016 Îct 31]. Available from: http://www.iso.org/iso/catalogue_detail.htm?csnumber=50174.

26. ISO Guide 35:2006 Reference Material — General and statistical principles for certification [cited 2015 Mar 14]. Available from: http://www.en-standard.eu/iso-guide-35-reference-materialsgeneral-and- statistical-principles-for-certification/.

27. State Standard Ð 8.691–2010 (ISO Guide 31:2000, MOD) GSI. Standard samples of materials (substances). General requirements for passports and labels. Moscow: Standartinform; 2012 (in Russian).

28. State Standard Ð 8.824–2013 (ISO Guide 34:2009, IDT). General requirements for the competence of reference materials producers. Moscow: Standartinform; 2014 (in Russian).

29. WHO manual for the establishment of national and other secondary standards for vaccines. WHO/IVB/11/03. June 2011.

30. Federal Law of the Russian Federation, June 26, 2008, ¹ 102-FZ «On ensuring the uniformity of measurements» (in Russian).

31. Resolution of the Government of the Russian Federation, November 2, 2009, ¹ 884. The position of the State service of reference materials of composition and properties of substances and materials (in Russian).

32. State Standard RMG 93–2009 GSI. Estimation of metrological characteristics of reference materials. Moscow: Standartinform; 2009 (in Russian).

33. State Standard Ð 50.2.058–2007 GSI. Evaluation of uncertainty of certified values of standard samples. Moscow: Standartinform; 2008 (in Russian).

34. Guideline of Eurachem/CITAC. Quantifying Uncertainty in Analytical Measurement. St. Petersburg: D. I. Mendeleev VNIIM; 2002 (in Russian).

35. International Dictionary of Metrology: Basic and general concepts and associated terms. St. Petersburg: Professional; 2010 (in Russian).

36. International Vocabulary of Metrology — Basic and general concept and associated terms (VIM). Guide JCGM 200:2008 [cited 2016 Mar 14]. Available from: https://iupac.org/publications/ci/2008/3006/ bw2_vim.html.

37. Volkova RA. Quality control of medical immunobiological preparations of chemical and immunochemical methods. Dr. Biol. Sci [thesis]. Moscow; 2009 (in Russian).

38. Volkova RA. Problems of metrological support of quality assessment methods of immunobiological drugs. In: I International Conference «Reference materials and measurement technology». Proceedings. Part 1. Ekaterinburg; 2013. P. 88–90 (in Russian).