Uncontrolled Revision of Documents Without QA Approval: A GMP Compliance Risk
Uncontrolled Revision of Documents Without QA Approval: A GMP Compliance Risk GMP Risk of Document Revisions Without QA Oversight and Approval Introduction to the Audit Finding 1. Undocumented Revisions When documents such as SOPs or protocols are revised without formal QA approval, changes go undocumented and unverified. 2. Bypassed Quality Gate QA serves as the…
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