The Slow Road Back

Schering-Plough Corporation met a Dec. 31, 2005 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.

Training Tip

Download a copy of the Consent Decree issued to Schering-Plough. Read through it and create a summary of what they were required to do. Use the summary in GMP training sessions to give people a sense of the breadth of observations and the power FDA wields in our industry.

The fundamental question to have training participants ponder is which is costlier – complying with GMP in the first place, or paying the $500 million in fines and paying for the three and one-half years of compliance actions.

Another question to ponder is whether Schering-Plough has been a fun place to work these last few years. Generally working under a Consent Decree is oppressive, and certainly not fun.

Stay Tuned

Schering-Plough still has to pass muster with FDA before the Consent Decree can be lifted.

Download the Consent Decree here - www.gmptrainingsystems.com/asp/resources.asp
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