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The form of the inspection report for compliance with GMP requirements will be changed

The Ministry of Industry and Trade of Russia has prepared amendments to the departmental order No. 261 dated February 4, 2016, which approves the application form for issuing an opinion on the compliance of a manufacturer (foreign manufacturer) of medicines for medical use with the requirements of the rules of good manufacturing practice (GMP), an inspection report based on the results of an inspection of a pharmaceutical manufacturer for compliance with the requirements of GMP rules and an opinion on the compliance of the pharmaceutical manufacturer with the requirements of GMP rules. The draft document was published on the regulation.gov.ru portal, its discussion will last until December 25, 2020.

It is clarified that in September 2020, the Government of Russia adopted Resolution No. 1361, which implies amending the Rules for organizing and conducting inspections of drug manufacturers for compliance with GMP requirements, as well as issuing conclusions on the manufacturer's compliance with these requirements. Thus, the decree established a mechanism for foreign drug manufacturers to provide a corrective and preventive action plan (CAPA) and a report on its implementation to an authorized institution, in order to eliminate the identified inconsistencies before sending an inspection report to the authorized body for making a decision on issuance (or refusal to issue) GMP conclusions.

The Ministry of Industry and Trade of Russia has developed a corresponding draft order, the purpose of which is to change the form of an inspection report drawn up based on the results of an inspection of a manufacturer (foreign manufacturer) of medicines for medical use for compliance with GMP requirements. The amendment provides for the completion of a special section indicating information on the results of the assessment of the plan of corrective and preventive actions and the corresponding copies of documents.

 

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