Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
Final guidance clarifies US FDA’s position on what is considered a major amendment subject to longer reviews, and what is considered a minor amendment subject to shorter reviews under GDUFA II.
Guidance from a European chemical industry group's API committee could help pharmaceutical manufacturers ensure that suppliers are applying GMP controls early enough in the active pharmaceutical ingredient manufacturing process, industry official tells ISPE meeting. While ICH Q7 guidance explains what to do when applying GMPs to APIs, the committee's document fills in some of the details on how to do it.
FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.
US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.