Gottlieb: Valsartan API Crisis Spurs Drug GMP Revision
FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.
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Outgoing FDA commissioner said his direct contact with center directors helped agency advance policies and helped centers solve their problems.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.