Schering-Plough Meets FDA Deadline for CGMP Improvements
ePT--the Electronic Newsletter of Pharmaceutical Technology
Schering-Plough Meets FDA Deadline for CGMP Improvements
Schering-Plough (Kenilworth, NJ, www.sch-plough.com) met a Dec. 31 deadline to revamp its current good manufacturing practices, as mandated by the US Food and Drug Administration in a 2002 consent degree.
According to the company, Schering-Plough completed all of the 212 significant steps and 30 validation actions required by the FDA, and is awaiting approval by the agency and third-party certification after an upcoming review process.
It has taken nearly three-and-a-half years for Schering-Plough to revalidate and work out deficiencies in their manufacturing plants that led to $500 million in fines and the suspension of approximately 70 products.
