CAPA Records Without Reference to Originating Failures: A Hidden GMP Risk
CAPA Records Without Reference to Originating Failures: A Hidden GMP Risk Why Linking CAPA Records to Originating Failures Is Non-Negotiable Introduction to the Audit Finding 1. Summary of the Compliance Gap Many pharmaceutical companies maintain Corrective and Preventive Action (CAPA) records that fail to explicitly reference the original deviation, complaint, audit finding, or non-conformance that…
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