U.S. FDA’s Draft Guidance on Process Validation Elicits Response from PDA Members

The public comment period for the U.S. FDA’s draft guidance on process validation generated more activity from PDA members since the Agency published its aseptic guidance for comment earlier in the decade. More than 400 comments were submitted to PDA, which established an online tool to collect the comments.

The comments were evaluated and categorized by a team of PDA volunteers and staff and a letter was sent to FDA on March 3. The PDA Task Force included Scott Bozzone, Senior Manager, Pfizer; Hal Baseman, COO, Valsource; Tim Ramjit, Senior Director, Schering Plough; Kris Evans, Director, Amgen; Mark Roache, Director, Bayer; Bob Dana Vice President, PDA and Iris Rice, Executive Coordinator, PDA.

The comments focused primarily on the following six topics from the FDA guidance: Wording and Terminology; Approach and Assurance for Commercial Distribution; Viral and Impurity Clearance; Concurrent Release; Scope and Legacy Systems; and Qualification, Documentation, Organization and Regulatory Impact.

The FDA guidance revises a 1987 guideline and describes the three stages and activities of process validation in a product’s life cycle: process design, process qualification and continued process verification.

PDA plans to offer a series of one-day public workshops at various locations from April until October around the world. Visit www.pda.org/processvalidation2009 to learn more.

A copy of the cover letter  for the Comments is available as a PDF.


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The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at http://www.pda.org/.