FDA Expecting Drug Manufacturing Quality Gains

An AssurX blog post says that FDA “continues to expect major improvements in pharmaceutical manufacturing quality management. While it’s anyone’s guess, given today’s federal government budget debate, it still appears likely FDA will continue its focus on GMP and data integrity issues through 2017. If an FDA investigator finds related problems at your facility, don’t expect a lot of sympathy.”

The post says that after a bit of a lull, the agency issued a batch of Warning Letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples of quality control problems found in the letters included unsatisfactory investigations, inadequate documentation, and poor data integrity practices, it says.

The post discusses some of the specifics in Warning Letters issued to Trone Health Services, Wockhardt, Megafine Pharma, and Mylan.