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Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier

On November 24, at the scientific-practical conference “Modern approaches for the expertise of medicines RegLek 2020” Director of “SID&GP” Vladislav Shestakov introduced a brief overview of the non-conformities ratio in the registration dossier for the total number and criticality of non-conformities over the past five years of the Russian GMP-Inspectorate work.

The main document that the inspection team works with during the inspection is the drug registration dossier. Particularly Module 3: manufacture and quality control. This document describes both the manufacturing process itself and the methods of quality control of the drug being manufactured. According to the Deputy Head of the Russian GMP-Inspectorate, inspections carried out by “SID&GP” inspectors since 2016 most often reveal major non-conformities, including those regarding the requirements of the registration dossier, rather than critical or other non-conformities. When analyzing the observations related to the requirements of the registration dossier, the inspection team, first of all, assesses the risks that these non-conformities represent for the quality of the final product.

Here the inspectors are guided by Part 3, Article 65 “Suspension of a drug use” Federal Law No. 61 “On Circulation of Medicines”. If we look at the statistics of revealed non-conformities with regard to the requirements of the registration dossier in terms of the deviations of the specified Part for 2018 and 2019, then most frequently deviations of Clause 3 are revealed: the manufacturer of a medicinal product has no documents confirming the compliance of quality with the requirements established at its state registration. This deviation is the most frequent – 48% of the total number of detected deviations specified in Clause 3.

Subparagraphs 1 and 2 are followed by approximately equal proportions – 22% and 19% respectively. Either there are deviations in the composition and (or) manufacture technology of a medicinal product that are different from those stated in the registration dossier. Alternatively, a medicinal product is manufactured at a site not specified in the registration dossier.

And there are minimal cases of Subparagraph 4 deviation, when the manufacturer has not eliminated the non-conformities identified during previous inspections or assessments.

“Deviations and non-conformities in the manufacturing process and quality control of the registration dossier may lead to serious consequences, up to suspension of a drug use,- said in the conclusion of his speech Director of the “SID&GP”. – Therefore, high-quality preparation and maintenance of the registration dossier in an actual state would withdraw a number of questions and reduce the number of identified non-conformities “.