The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
On September 5, Russian Prime Minister Mikhail Mishustin signed Decree No. 1361 amending the rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements, as well as issuing the certificates on the compliance of drug manufacturers with the GMP standards.
The amendments approved by the Chairman of the Government of the Russian Federation have been adopted to bring Russian legislation into compliance with the Rules of conducting pharmaceutical inspections approved by the Eurasian Economic Commission Council. These amendments concern the requirements approved by the Russian Government Decree of December 3, 2015 No. 1314 “On Determining Compliance of Pharmaceutical Manufacturers with the Requirements of Good Manufacturing Practice”. In particular, now the inspection report can be made without filling in the section containing the final recommendations and conclusions, if during the inspection of the foreign manufacturer were identified the non-conformities with the requirements of the GMP rules, but the manufacturer has submitted to “SID&GP” his CAPA plan and copies of the documents, prepared in the appropriate manner, containing the measures on its implementation.
The foreign manufacturer or its authorized representative within a period not later than 60 working days from the date of the inspection report receipt (without filling in the section containing final recommendations and conclusions) has the right to submit to the authorized institution a letter with the attached CAPA plan and copies of documents prepared in accordance with the established procedure, containing measures for its implementation, as well as a document confirming the payment for additional inspection services. In case of sending the CAPA plan, the payment for additional inspection services has to be made according to the procedure outlined in the agreement between the foreign manufacturer and “SID&GP”. The commission of inspectors within 25 working days from the date of the CAPA-plan receipt by “SID&GP”, evaluates it and prepares the final part of the inspection report containing final recommendations and conclusions. If the foreign manufacturer does not provide a CAPA plan within the specified period, the commission of inspectors within 3 working days from the date of expiration of the period established for the CAPA plan submission, prepares an inspection report on the letterhead in 3 copies, which is signed by all members of the inspectors` commission. After that, within 3 working days, one copy of the inspection report is sent to the foreign manufacturer or its authorized representative, the second copy is sent to the authorized body, and the third copy is to be kept in the authorized institution.