The system of secondary reference standards in drug quality control laboratories
Abstract
Pharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary reference standards (SRS) of a facility. The article describes the experience in the development and implementation of the SRS system in Ukraine within the transition to a two-level system.
About the Author
D. A. Leontiev
Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines
Russian Federation
Russian Federation
References
1. 5.12. Reference standards. European Pharmacopoeia 8th edition. P. 699–702. European Directorate for the Quality of Medicines & HealthCare (EDQM). Council of Europe — 7 allee Kastner. CS 30026, F-67081 Strasbourg, France. Available from: http://online6.edqm.eu/ep802/.
2. Standard samples of structure and properties of substances and materials. Interstate standards. GOST 8.315–97. Interstate Council for Standardization, Metrology and Certification. Minsk; 1997 (in Russian).
3. Analytical Data—Interpretation and Treatment. The United States Pharmacopeia. Rockville: The United States Pharmacopeial Convention, Inc. USP 36–NF 31. Online Edition.
4. International Vocabulary of Basic and General Terms in Metrology. ISO, Geneva; 1993.
5. Leontiev DA. Pharmaceutical standard samples. In: Georgievskiy VP, ed. Analytical chemistry in the creation, standardization and quality control of medicines. V. 3. Kharkov: NTMT; 2012. P. 1064–1118 (in Russian).
6. ISO. 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: ISO; 2005.
7. Wolf B, Ermer J. Use of Reference Standards and Quality Control: experiences and unmet needs. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3–4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
8. State Pharmacopoeia of the USSR. 11th ed. Vol. 1. Moscow: Meditsina; 1987 (in Russian).
9. Arzamastsev AP, Dorofeev VL, Sadchikova NP. State standard drug samples (project of general pharmacopeia article). Vedomosti Nauchnogo tsentra ekspertizy i gosudarstvennogo kontrolya lekarstvennyh sredstv 2000; (3): 24–26 (in Russian).
10. Reference Standards. The United State Pharmacopeia. Rockville: The United State Pharmacopeial Convention, Inc. USP 37–NF 32. P. 46–48. Online Edition.
11. GMPPIC/S.Available from: http://www.picscheme.org/publication.php.
12. EU GMP. Available from: http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm.
13. Common technical document for the registration of pharmaceuticals for human use quality overall summary of module 2 and module 3: quality (CPMP/ICH/2887/99 - Quality), July 2003. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002725.pdf.
14. Jean-Louis Robert. Assessors viewpoint: expectations and findings in dossiers. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3–4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
15. Clark J. Pharmaceutical Reference Standards at US FDA: Review and cGMP. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3–4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
16. Hecker T. Inspector’s viewpoint: expectations and findings in GMP inspections. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3–4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
17. Leontiev D. Development of the National System of Medicine Reference Substances in Ukraine. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3–4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
Review
For citations:
Leontiev D.A. The system of secondary reference standards in drug quality control laboratories. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):50-55. (In Russ.)
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