Molly Bowman
Editorial Director, Generic and Investigational Drugs Clarivate Analytics

REGULATORY

In the second quarter of 2017, some of the US FDA enforcement actions included warning letters issued to active ingredient manufacturing facilities belonging to Sal Pharma, Divi’s Laboratories Ltd., Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. The British MHRA published the annual report on inspection deficiency findings. The UK GMDP performed 324 inspections is 2016, 242 in the UK and 82 outside the country.

The EMA and FDA also published a report summarizing the outcome of the five year quality by design (QbD) pilot program, which concluded in April of 2016. Pharmaceutical QbD is a systematic approach to determine the product and process characteristics that meet specific criteria. These may include properties of the active ingredient such as polymorphism or impurity profiles. Once these are defined, various reactions can be investigated and the outcomes of each step fully analyzed. Then process conditions can be adjusted to minimize any impurities or undesired outcomes. The joint agency program was initiated to facilitate the implementation of QbD concepts and harmonize regulatory decisions. The agencies jointly developed and each p ...