Requirements and application of GMP regulations in API manufacture

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.