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Devicemaker’s Guide to Process Validation

November 2012
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When the FDA clarified its guidance on process validation for drugmakers, medical device companies were left in the dark. The CDRH did not sign on to a new guidance, leaving in place only the old and confusing guidance that dates back years.

But time hasn’t stood still on the manufacturing floor: New and more complex manufacturing processes emerge every year, greater outsourcing leaves devicemakers relying more on third-party manufacturers, and international standards continue evolving. Devicemakers need to be sure their process validation systems have kept pace with reality.

This timely document takes you step-by-step through the most complex, challenging process validation compliance problems, filling in the gaps left in the available guidance. Among questions it addresses and resolves:

  • What processes should be validated? The simplified decision tree included in this report removes all questions
  • If a company uses sampling plans in lieu of a validated process, what percentage of sampling is adequate? Discover how the FDA has addressed this issue in warning letters
  • When the GHTF talks about operation qualification, does it mean the same as when the FDA talks about operational qualification? The report includes a simple crosswalk that clarifies the FDA’s meaning

You’ll discover specific solutions to issues and questions that bedevil many devicemakers. The report includes:

  • An overview of the existing requirements for process validation from the Quality Systems Regulation and Quality Systems Manual
  • How the FDA inspects devicemakers for process validation compliance
  • Latest thinking of international and US regulators on process validation approaches contained in GHTF guidelines
  • Lessons from warning letters on the FDA’s evolving expectations for process validation
  • And much more

Lacking specific new guidance, FDA’s intentions for process validation must be identified through Warning Letters, official statements and official documents. FDAnews has done the hard work for you. Until CDRH issues its long-awaited guidance, Devicemaker’s Guide to Process Validation will keep you in compliance.