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Industry Urges EU to Align Draft Validation Guidance with ICH and FDA

This article was originally published in The Gold Sheet

Executive Summary

European pharmaceutical manufacturers say that the European Union’s draft process validation guidance should be better aligned with the International Conference on Harmonization and FDA lifecycle approaches to process validation and that major changes are needed before it is a workable guideline. EMA issues two concept papers to revise Annex 15 and Annex 17 to reflect lifecycle approaches.

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