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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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EU Inspectors to Focus on Integrity of Process Validation Data

The revised Annex 15 is prompting EU inspectors to take a new look at data integrity problems. One EU inspector warns industry to be vigilant in looking for such problems in validation reports, and shares some news about Europe’s three-batch minimum for process validation.

Three-batch Process Validation Lives on in Europe

The European Medicines Agency’s final process validation guidance fails to fully incorporate science- and risk-based approaches, asserts Europe’s pharmaceutical industry. The EMA is still collecting comments on the revised Annex 15 that covers the qualification and validation of facilities used in manufacturing.

Regulatory Updates In Brief

PIC/S GMP guide revised; EU GMP Annex 15 rewrite drafted; Reports OIG is preparing; Quality guidance FDA is drafting.

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