News

Posted On: 01/04/2006

Schering-Plough Completes cGMP Work Plan

PharmaManufacturing.com

Schering-Plough Corp. (Kenilworth, N.J.) announced Jan. 3 that it has informed the U.S. Food and Drug Administration (FDA) that it has completed all of the 212 significant steps and 30 validation actions required by Dec. 31, 2005, under its consent decree.

"The timely completion of our cGMP Work Plan and Validation Certification Program represents another significant milestone as we work to build the new Schering-Plough," said Fred Hassan, Schering-Plough chairman and CEO. "Many Schering-Plough colleagues worked tirelessly and with a sustained focus to achieve this important goal. We remain committed to continuing our quality and compliance programs and look forward to the time when we can request that the consent decree be lifted."

The obligations and requirements completed by the company under the consent decree are subject to certification by an external third party and review and approval by the FDA. The company cannot predict when or how long the FDA may take to complete a review of the company's completion of its cGMP Work Plans and validation program requirements under the decree. For more information on Schering-Plough, visit www.schering-plough.com.