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

Abstract

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.

Keywords

• 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