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Do I hear three? Number of process validation batches to be set by protocol

This article was originally published in The Gold Sheet

Executive Summary

FDA's upcoming process validation guidance will reflect a combination of traditional and QbD-like process design requirements, Joseph Famulare, deputy director of CDER's Office of Compliance, said at an Oct. 15 meeting sponsored by Pharmaconference and the University of Rhode Island College of Pharmacy in Bethesda, Md. He noted that the upcoming guidance has involved all parts of the centers for drugs, biologics and veterinary medicine and the Office of Regulatory Affairs. He further noted that "if you have a lot of knowledge management, this can be factored into the protocol. The protocol will be used to justify your batch number." Echoing the remarks of other FDA officials on the upcoming guidance, Doug Ellsworth, FDA's New Jersey District Director, said that "the Barr decision produced the three batches. Now everyone denies saying it. Three batches are gone. There is now a lifecycle approach to validation.
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