🧪 Standard Operating Procedure (SOP) for Out of Specification (OOS) Investigation 1. Introduction An Out of Specification (OOS) result is a test result that falls outside approved acceptance criteria. Proper investigation of OOS results is essential to ensure data integrity, product quality, and regulatory compliance. 2. Purpose To define a scientifically sound and compliant procedure for identification, investigation, documentation, and closure of OOS results in accordance with FDA, MHRA, EMA, WHO, ICH, and PIC/S guidelines. 3. Scope Applicable to all OOS results generated during raw material, in-process, finished product, stability, validation, and method transfer testing. 4. Responsibilities Analyst: Report OOS immediately and secure all data. QC Supervisor: Initiate and review Phase I investigation. Quality Assurance: Oversee investigation and approve conclusions. Manufacturing: Support Phase II investigation whe...
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