FDA Collates GMP Data Integrity Advice Into Draft Guidance

This article was originally published in The Tan Sheet

02 May 2016
News

Bowman Cox @bowmancox bowman.cox@informa.com

Executive Summary

A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.

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FDA Collates GMP Data Integrity Advice Into Draft Guidance

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Executive Summary

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