On March 3, the Ministry of Justice of Russia registered an order of the Ministry of Industry and Trade of Russia dated 29.01.2021 No. 284, which amends annex 2 to the order of the Ministry of Industry and Trade of the Russian Federation dated February 4, 2016 No. 261 “On the approval of application forms for the issuance of an opinion on the compliance of a drug manufacturer (foreign manufacturer) to the requirements of the Good Manufacturing Practice (GMP) rules, the inspection report on the results of the inspection of the manufacturer and foreign manufacturer of drugs for compliance with the requirements of the GMP rules and the conclusion on compliance of the manufacturer (foreign manufacturer) of drugs with the requirements of the GMP rules. ” The corresponding document is published on the official Internet portal of legal information.
The changes relate to the inclusion of the Corrective and Preventive Action Plan (CAPA) evaluation item. As a result of the evaluation of the CAPA system, the inspectors conclude that the classification can be adjusted and the number of inconsistencies identified.
The enterprise CAPA system and its processes should be designed to systematically analyze and respond to quality issues, taking into account risks. The system shall provide for algorithms of corrective and preventive actions to ensure their effectiveness and provide confirmation that these actions will not negatively affect the product.