GMP inspection

Organization and conduct of inspection of foreign manufacturers of medicines for compliance with the requirements of GMP rules

The company «Neurometrix» provides services to support the inspection of the compliance of the manufacturer of medicines with the requirements of the Rules of Good Manufacturing Practice (GMP) of the Eurasian Economic Union, according to the approved decision of the Council of the Eurasian Economic Commission of November 3, 2016. No. 77 «On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union» and Resolution of the Government of the Russian Federation No. 1314 of 03.12.2015 «On determining the compliance of manufacturers of medicines with the requirements of the rules of good manufacturing practice» with other regulatory acts of the Russian Federation. According to part 4 of Article 18 of the Federal Law of the Russian Federation of April 12, 2020 No. 61-FZ «On the Circulation of Medicines» if the production of a medicinal product is carried out outside the Russian Federation, all pharmaceutical companies must provide a copy of the conclusion on compliance with the requirements of good manufacturing practice (GMP).

Please pay attention to the fact that if there are several production sites during the production of a medicinal product, then the inspection takes place at each of them and the conclusion is drawn up for each site separately, depending on the result of the inspection.

List of services provided:

• Consultation on GMP inspection issues;
• Collection and preparation of a package of documents for submitting documents for inspection for compliance with the requirements of good manufacturing practice (GMP);
• Submission of a package of documents to the state authorized and subordinate bodies of the Russian Federation;
• Support and negotiations with the authorized bodies of the Russian Federation;
• Departure for the audit of the production site for compliance with the requirements of good manufacturing practice (GMP);
• Departure to the production site with inspectors and support of inspection;
• Support in the preparation and preparation of a package of documents for submission to CAPA.