FDA Drug GMP Warning Letters from FY 2014
This article was originally published in The Gold Sheet
You may also be interested in...
Outsourcer PharMedium has agreed to suspend sterile drug compounding at one of its facilities until it remedies GMP problems under the terms of a consent decree. A federal complaint said that the firm ignored a slew of microbiological and quality problems.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.