Russian GMP Inspection of pharmaceutical manufacturers

Russian GMP inspection of foreign manufacturers

Obligatory GMP inspection of manufacturing site(s) by Russian authorities is needed for any international manufacturer from 2016.

Starting Feb 2016 it has become evident that last amendments to the Russian Federal law №61FZ "On circulation of medical drugs" ultimately came into force without any transition period.

Key feature of that regulatory update is that Russian GMP conclusion became obligatory part of a registration dossier for any finished drug product and active pharmaceutical substance registration (for API - enrollment to the National register).

Absence of Russian GMP conclusion in a finished drug product or API registration dossier results in refusal of registration expertise from the Ministry of Health (MoH).

On Feb 15th, Federal State Institution “State Institute of Drugs and Good Practices” (FSI SID&GP) has been officially empowered by the Ministry of Industry and Trade (MIT) to conduct pharmaceutical manufacturing inspections resulting in GMP conclusion issued by MIT. At the moment it is the only institute in Russia that provides corresponding GMP-compliance expertise  and GMP inspections as such.

Starting 2017, some types of CMC variation dossier (e.g. alternative manufacturing site, addition of new manufacturing site, change of QC testing methods, change in manufacturing process etc.) should contain Russian GMP conclusion as well.

As of Feb 2016, several foreign manufacturers already applied to MIT for the GMP inspection to receive Russian GMP conclusion needed for state registration of their products.

We provide all organizing and supporting activities for before, during and after Russian GMP inspection procedure: 

1. Preparation of the dossier for the GMP inspection;
2. Applying the file to Ministry of Industry and Trade of Russia;
3. Paying official state duty;
4. Getting agreement with FSI SID&GP for the inspection;
5. Official communication with FSI SID&GP;
6. Optimizing applicants "queue" time with FSI SID&GP;
7. Communication with FSI SID&GP to duly adjustments of documentation/processes/facilities according to the information from a site master file (pre-audit);
8. Accompanying the inspection;
9. Providing translation service on site from certified professional agency;
10. Communication with the inspection team after the audit, resolving questions;
11. Getting Russian GMP conclusion from Ministry of Industry and Trade of Russia.

The complete procedure of obtaining Russian GMP conclusion is expected to take from 4 to 8 months due to queue of the applicants and limited number of inspectors.

Due to managing Russian GMP inspection as integral part of our service for a finished product or API registration from 2016 and our time optimization of every registration process (for example, we put on the processes in parallel: import and preliminary QC testing of samples; GMP inspection procedures; biowaver or bioequivalence study - if required), we minimize additional time for inspection procedures - our timeline adds up to 2 additional months only for the whole FDP or API registration process.

In many cases our Russian GMP inspection service can be integrated to the registration timeline "seamlessly", adding no extra time to overall registration term.