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New Validation Guidance Causes a Stir

By: Alex D. Kanarek, Ph.D.
Reprinted with permission of BioProcess International, June 2009

In November 2008, the US FDA finally issued a new draft guidance on process validation. The new guidance is intended to reflect some goals of the FDA’s Pharmaceutical GMPs for the 21st Century, an initiative that was finalized in 2004. The new draft is to be applied to manufacturing human and veterinary drugs, biological and biotechnology products, finished products and APIs. Its key principle is alignment of process validation activities with the product development life-cycle and the use of quality by design (QbD).