Sampling in modern pharmaceutical analysis
Abstract
Sampling procedure is an integral part of the drug quality control system. Objective science-based sampling is an important operation when only a small amount of a material is taken and it is representative for the analysis of the whole product batch. Reasoned conclusions about drug quality can only be based on the results of tests conducted on representative samples, taken in accordance with certain rules and regulations. For the purpose of harmonization with foreign normative documents, systematization and updating of the requirements for sampling, specifying their conditions, general pharmacopoeia monograph «Sampling» has been developed. It regulates general rules and special aspects of drug sampling procedures for the purpose of drug quality control. The general pharmacopoeia monograph «Sampling» consolidates and classifies the materials of legislative and regulatory documents of the Russian Federation, the WHO, the EU and international pharmacopoeia monographs.
About the Authors
T. N. Bokovikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. P. Gernikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. I. Sakanyan
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. D. Bunyatyan
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
L. I. Shishova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
L. A. Stronova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
S. A. Manaeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. General Monograph «Sampling of medicines». The State Pharmacopoeia of the USSR. 11th ed. Issue 2. 1990 (in Russian).
2. The International Parmacopoeia. 4th edition.
3. United States Pharmacopeia. 35th edition (USP 35-NF30).
4. European Pharmacopoeia. 8th edition.
5. British Parmacopoeia.
6. General Monograph «Sampling». The State Pharmacopoeia of Republic of Belarus. V. 1. Minsk: Tsentr ekspertiz i ispytaniy v zdravoohranenii; 2006 (in Russian).
7. Federal Law of the Russian Federation ¹ 61-FZ, 12.04.2010 «On Circulation of Medicines» (in Russian).
8. Resolution of the Government of the Russian Federation ¹ 982, 01.12.2009 «On the approval of a single list of products subject to mandatory certification, and a single list of products, conformity assessment which takes the form of acceptance of the declaration of conformity» (in Russian).
9. Resolution of the Government of the Russian Federation ¹ 1043, 15.10.2012 «On Approval of the federal state supervision in the field of medicines» (in Russian).
10. National Standard of the Russian Federation «Rules of production and quality control of medicines». GOST R 52249–2009 (in Russian).
11. State Standard R 52537–2006. Production of medicines. The quality assurance system. General requirements (in Russian).
12. The rules governing medicinal products in the European Union. T4. EU rules on good manufacturing practice for medicinal products for human and veterinary use (GMP EU) «Good manufacturing Practice for Medicinal Products for Human and Veterinary Use».
13. WHOguidelines for sampling of pharmaceutical products and related materials. Annex 4. WHO Technical Report Series.¹ 929.2005.
Review
For citations:
Bokovikova T.N., Gernikova E.P., Sakanyan E.I., Bunyatyan N.D., Shishova L.I., Stronova L.A., Manaeva S.A. Sampling in modern pharmaceutical analysis. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):33-36. (In Russ.)
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