Investigation Failures, Root Cause Problems Continue To Bedevil Manufacturers
FDA and industry experts discuss avoiding old pitfalls and exploring new investigation models at FDA/PDA conference, as pharmaceutical manufacturers continue to struggle with failure investigations and discerning the root cause of quality defects.
You may also be interested in...
FDA issued 42 GMP drug warning letters in FY 2015, a 6% reduction compared to the previous year. The agency’s enforcement efforts continue to focus on compounding pharmacies and foreign manufacturing sites, while data integrity lapses continue to grow and a UK MHRA inspector said that a different mindset is needed to resolve these problems.
Inadequate control of contamination – in people, processes and places – was the dominant problem found in the 45 drug GMP warning letters that FDA issued in FY 2014. More than half went to compounding pharmacies.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”