GMP Failure: No SOP for Regulatory Audit Preparation
GMP Failure: No SOP for Regulatory Audit Preparation Absence of Audit Preparation SOP: A Critical Inspection Readiness Gap Introduction to the Audit Finding 1. Audit Readiness Expectation Regulatory authorities expect pharmaceutical companies to have defined SOPs outlining how they prepare for GMP inspections. 2. The Finding Explained Absence of a formal SOP for audit readiness…
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