Locations inspection manufacturers

drugs

In compliance with the rules
of good manufacturing practice,
activity which is beyond
outside the Russian Federation.

 

The geography of our audits covers

Russia and CIS countries

Western and Eastern Europe,
countries of Southeast Asia and
the Middle East, India, Japan

News

20 Jan
In the next two months, all market representatives should become participants in the labeling system.

According to a new decree of the Government of the Russian Federation No. 1954, all participants of the medicines circulation must register in the labeling system from January 1 to the end of February 2020. Starting July 1, 2020, medicines circulation without digital codes will be banned.

16 Jan
Expert Consulting Seminar “Transition to the EAEU GMP Rules”

Transition to the EAEU GMP rules. Regulatory requirements and regulatory expectations regarding the validation of computer-aided systems. Validation of equipment for labelling.

17 Dec
Online conference “Audit inspections of pharmacovigilance system of marketing authorizations holders”

On December 20, the best specialists in the field of pharmacology will make presentations at an online conference on the topic “Audit inspections of pharmacovigilance system of marketing authorizations holders”.

16 Dec
In February 2020, an experiment on the labeling of medical devices will start in the Russian Federation

In February 2020, a pilot project on the labeling of medical devices will be launched in Russia. The draft amendments to the Decree of the Government of the Russian Federation dated December 14, 2018 No. 1556 “On approval of the Regulation on the system for monitoring the movement of drugs for human use” is submitted for public discussion

12 Dec
Pharmaceutical inspectors will be able to take product samples during inspections

The Ministry of Health of Russia makes amendments to Federal Law No. 61 “On the Circulation of Medicines”, which will allow, if necessary, during the inspection to perform sampling of materials or products that will subsequently be sent for testing to authorized testing laboratory of the Russian Federation.

28 Nov
Labeling pharmaceutical products: success in detail

The introduction of drug labeling is a multi-purpose and complex project. What changes do the pharmaceutical manufacturers need to make in their business processes and what to direct attention to when choosing software and hardware? This was told by experts from KPMG, Navicon and Utrace

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"GMP-Project" - a company that specializes in assisting in the preparation of the inspection of manufacturers of medicinal products for compliance with the rules of good manufacturing practice, the activity of which is located outside the Russian Federation.