Temporary SOP Changes Without Change Control: A Hidden Compliance Gap
Temporary SOP Changes Without Change Control: A Hidden Compliance Gap Unapproved Temporary SOP Changes: A Risky Shortcut in GMP Environments Introduction to the Audit Finding 1. Unrecorded Emergency Changes Violate GMP Temporary alterations to SOPs during emergencies must be documented under formal change control. Failure to do so constitutes a serious compliance gap. 2. Common…
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