EMA: New Notes for Guidance on Process Validation

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In March 2012, EMA replaced the Notes for Guidance on Process Validation (CPMP/QWP/848/96). This guidance, similar to the recently issued FDA guideline, incorporates many of the concepts noted in the ICH guidelines Q8, Q9 and Q10. The guideline is somewhat harmonized with the current FDA
guidance on Process Validation. The guidance document does not deal with legacy products, but rather addresses new products and the approach to ensure appropriate process validation is performed.

Process validation is addressed by using four different approaches: Traditional process validation, Continuous process verification (CPV), Hybrid approach and Continued Process Verification during the Lifecycle. Each approach is described within the guidelines. There are also definitions that are repeated in this guideline from ICH Q8 and Q9.

Read the new guidance here.