Starting from January 2017, overseas pharmaceutical manufacturers are allowed to register new pharmaceutical product(s) in Russia only if they hold Russian GMP certificate issued by Russian Ministry of Industry.
This new regulatory condition applies both to API and FDF markets. Due to complexity and peculiaruty of the RU GMP procedure overseas pharmaceutical manufacturers are unlikely to succeed using their own resources only.
However, we, Protek-SVM, are ready to provide you with full range of services for facilitation of RU GMP certification procedure.
Our broad experience, coupled with team of highly qualified professionals, makes us the best RU GMP certification agent available.
WE ARE HEREBY PLEASED TO OFFER YOU THE FOLLOWING SERVICES:
We perform compilation of the dossier required by the Ministry of Industry and submit it along with the application.
This procedure normally includes:
Composition of all needed documents as per requirements of Russian Law (accompanied with corrections and harmonization)
Translation and notarization;
Submitting the dossier to the Ministry of Industry and communication with the Ministry on all matters regarded to the dossier.
We perform preliminary inspection of the manufacturing site in order to make sure that the site fully complies with RU GMP requirements. This measure allows to reveal and eliminate any flaws or inconsistences and thereby gradually increase chances of passing the actual RU GMP audit.
This procedure includes:
Full inspection of the manufacturing lines;
Audit of the water-purification/HVAC systems;
ASSISTANCE DURING OFFICIAL INSPECTION
According to our practice, official audit is always followed by certain amount of misunderstanding between the auditors and the manufacturers’ team. This misunderstanding may result in wrong conclusions from the auditors’ side and, therefore, affect the audit outcome in an unpleasant way.
In order to avoid that, we offer our assistance during official inspection. According to our practice, this kind of service helps develop solutions for most of the problems occurring during the audit, hence it greatly contributes to successful certification.