«Requirements and Application of GMP Rules to Manufacture of APIs» – an open expert-advisory workshop
On 20-21 December, an open expert-advisory workshop on the topic «Requirements and Application of GMP Rules to Manufacture of APIs» will be held. The workshop is organized by the State Institute of Drugs and Good Practices together with Pharmstretegy, Ltd. 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 manufacture of APIs, and GMP rules as applied to APIs have some peculiarities as compared with manufacture of finished dosage forms.
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 following speakers and experts:
Madina Sottaeva – Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI «SID & GP»;
Vladimir Orlov – Line Manager of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI «SID & GP»;
Eugenia Arakcheeva, Assistant of General Director of PHARMSTRATEGY, LTD.
- The issues of the legal and regulatory framework of pharmaceutical activities in Russian and the EAEU were discussed by participants of the VI All-Russia Congress
- The experts of FSI «SID & GP» took part in the meeting of Indian manufacturers and suppliers of the pharmaceutical industry with Russian colleagues
- Russian drugs penetration to the key segments of the pharmaceutical market rose in the 1st half of 2018
- The State Institute of Drugs and Good Practices Of the Ministry of Industry and trade of the Russian federation Celebrates 45th Anniversary
- The experts of FSI «SID & GP» took part in the VI International Forum «Anti-counterfeit 2018»