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OTC Drugs

FDA Collates GMP Data Integrity Advice Into Draft Guidance

This article was originally published in The Tan Sheet

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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A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity.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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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