Missing Acceptance Criteria or Critical Limits in SOPs: A GMP Documentation Flaw
Missing Acceptance Criteria or Critical Limits in SOPs: A GMP Documentation Flaw SOPs Without Acceptance Criteria or Critical Limits: A Key GMP Documentation Deficiency Introduction to the Audit Finding 1. Vague Instructions Some SOPs describe procedures but fail to specify the required acceptance criteria or tolerances. 2. Critical Limit Omissions Parameters like temperature, pH, or…
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