The Quality Lowdown: US FDA Finding New Crop Of Data Integrity Problems
Manufacturers warned to keep better electronic records and not falsify data in recent warning letters, ICH adds three residual solvent limits for pharmaceuticals, and the Polish authority hits firm for GMP noncompliance.
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The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
Calvin Scott, Acella Pharmaceuticals, Soluciones Cosmeticas and TAKA USA warning letters highlight issues with quality units, process control and specifications.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”