23 November 2005
Questions and Answers on PAT (update concerning process validation)
A number of answers to frequently asked questions on PAT been added to
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
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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