GMP inspection

 

Requirement of mandatory inspection of foreign manufacturers by Russian inspectors came into force on 01.01.2016. Authorized federal regulatory agency on this issue is Ministry of Industry and Trade of the Russian Federation (in brief, Minpromtorg of Russia) (http://minpromtorg.gov.ru/, http://minpromtorg.gov.ru/activities/services/licensing/). Expert organization conducting inspection and issuing inspection reports is Federal Budgetary Enterprise ”State Institute for Medicinal Products and Good Practices” (FBU GILSiNP) of the Ministry of Industry and Trade of the Russian Federation http://gosgmp.ru.

GMP compliance report is required from medicinal product manufacturer if he is planning to obtain Marketing Authorization for his products in Russia. Availability of this document (called GMP certificate outside of Russia), issued by authorized body of manufacturer country does not release Manufacturer from the necessity of Russian inspection. Manufacturer shall be visited by Russian inspectors obligatorily, and there will be no exception.

In case several sites are involved in product manufacture, all of them should be inspected. Individual application is submitted for each facility and separate inspections are conducted. All documents are submitted in Russian, including Site Master File.

Our company offers a service of applying for GMP compliance report and supports the entire procedure up to inclusion of manufacturer in GMP inspection schedule.

As part of the service, we shall do the following:

• prepare and approve with the customer a package of documents for a GMP compliance inspection of the manufacturer;
• translate the required documents submitted my manufacturing site;
• submit application to Minpromtorg of Russia and monitor inclusion of manufacturer in GMP inspection schedule.

All documents are submitted in Russian, including Site Master File.

List of documents required for GMP Inspection:

1. Application on the issue of GMP Compliance report.
2. A copy of the document confirming credentials of authorized representative of manufacturer or foreign manufacturer.
3. A copy of Site Master File.
4. Information on revealed non compliances of medicinal product quality, including information on withdrawal of medicinal products from civil circulation for the period of at least 2 years prior to submitting application.
5. A list of medicinal products manufactured at the production site of manufacturer or foreign manufacturer under inspection.
6. A copy of the license issued by authorized agency of foreign manufacturer country (or a document authorizing foreign manufacturer to manufacture medicinal products) and its translation into Russian legalized in accordance with the established procedure (if such document is required by legislation of foreign manufacturer country).
7. A Letter of consent to inspection from the foreign manufacturer.

Average time from starting preparation of documents for submitting application is 1.5 months. Another 2 months pass between submitting documents to the Ministry of Industry and Trade and appointing the date of inspection.