The problem of a unified approach to certifying standard samples for drug quality control

Due to the Russian pharmaceutical industry's great demand for standard samples (SSs), the authors have carried out a content analysis of the legislative and regulatory framework that defines the terminology for SSs and their requirements. They present the general classification of SSs, have identified and discussed the topical problems of the adequacy of translating the foreign normative documents in terms of terminology and establishing the quality indices for SSs depending on how they are used. An analysis of regulatory documents has revealed critical differences in the requirements for estimation of SS quality indicators (identity, purity, and assay). However, General Pharmacopoeia Article 1.1.0007.18 «Standard Samples» in the 14th edition of the Russian Federation's State Pharmacopoeia differentiates the requirements for SSs according to their intended use: Pharmacopoeia SS (PSS) for identity, PSS for testing for purity and impurities, and PSS for assay. The GOST lacks this difference and all the requirements are the same for a universal SS. It is shown that it is necessary to certify SS in such a way that if necessary, the latter can be used as a universal one and meet the requirements for estimating the corresponding individual indicator.

standard sample, pharmacopoeia standard sample (PSS), state standard sample (SSS), certification of standard samples