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23 November 2005

EMEA:
Questions and Answers on PAT (update concerning process validation)

A number of answers to frequently asked questions on PAT been added to the website.

  • When PAT is implemented will the manufacturer be allowed to make changes to the process without need for regulatory "approval"?

  • Is it possible for a product to have two specifications - one for real-time release based on on-line measurements and another for end-of-life testing?

  • Will it be possible to widen the limits for an "approved product and process specification" if, post-approval, such changes are found to have no significant affect on product quality?

  • Would EMEA consider a validation strategy, which eliminated the need for product equivalence validation (e.g. PQ with 3 batches) if the product/ process signature were qualified at the development stage

You will find the answers to these questions at the European Medicines Agency website

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