GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says
Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.
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FDA and PIC/S inspection approaches are evolving, with FDA focusing on beta-lactams, CMOs and contract labs; and PIC/S working on inspection sharing, harmonizing on deficiencies, data integrity guidance and inspector training. Meanwhile, Dr Reddy’s gets warning letter, AstraZeneca sees EU noncompliance and four firms added to FDA’s drug GMP import alert.
With its acquisition of Hospira, Pfizer joins the ranks of pharmaceutical companies struggling to eke out a profit from aging sterile injectables facilities without shutting them down for badly needed upgrades for fear of triggering additional drug shortages. Meanwhile, flexible, modular next-generation facilities that could add capacity where needed are on the horizon.
The European Medicines Agency is inviting feedback on a draft guideline that explains how companies that make different medicinal products at shared manufacturing facilities should review and evaluate pharmacological and toxicological data of individual products to tackle cross-contamination issues1.