Current problems with the standard samples of medicines in the Russian Federation

Standard samples (SSs) for drug quality control procedures require a special approach, which is marked by biological agent (BA) control methods in general and biological control ones in particular. The list of SSs of the Research Center for Examination of Medical Products (RCEMP) currently includes 61 names for SSs. By analyzing international guidelines and recommendations and by generalizing the experience of the RCEMP in developing, certifying, and using SSs to control BA quality and to consider the Russian normal legal base of state SSs and the documents of the Eurasian Economic Union, the authors have proposed the main study areas to improve SSs, which include the elaboration of approaches to validating similar (same type) biological, methods for certifying SSs; the development of the order in which alternative approaches are applied to statistically processing test results when certifying SSs of medicines in the absence of a normal distribution of results; the formation of Russia's requirements for the development, quality assessment, and procedure for certification of both primary and secondary SSs of a manufacturer; the development of SS requirements for qualitative (not quantitative) procedures.

medicines, biological standard samples, certification, biological methods, validation