On 20-21 December, the State Institute of Drugs and Good Practices (FSI “SID&GP”) jointly with Pharmstrategy Ltd. will held an open expert-advisory workshop “Requirements and Application of GMP Rules to Manufacture of APIs”.
The workshop is organized within the program of promoting implementation of the best practices in the Russian pharmaceutical industry.
Compliance with the requirements of Good Manufacturing Practice (GMP) in manufacture of active pharmaceutical ingredients (APIs) is one of the key factors in obtaining the drug of the required quality. This is why regulatory authorities traditionally have an increased focus on GMP rules to be applied to APIs.
\The workshop will provide a detailed analysis of the regulatory documents establishing the requirements for manufacture of APIs in Russia and abroad. First of all, the priority will be given to the following documents:
- Good Manufacturing Practice approved by the Order No. 916 as of 14 June, 2013 by the RF Ministry of Industry and Trade (Part II and relevant Annexes);
- EAEU Good Manufacturing Practice (Part II and relevant Annexes);
- EU Good Manufacturing Practice (Part II and relevant Annexes);
- ICH Q7 (GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS);
- US FDA Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
A particular emphasis will be given to discussion of the most frequent non-conformities witnessed during regulatory GMP-inspections of API manufacturers.
The workshop will feature the experts: Madina Sottaeva (Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI “SID & GP”), and Vladimir Orlov (Line Manager of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI “SID & GP”).
Registration details can be found at FSI “SID & GP” website