Pharmaceutical Labs Handling OOS results

Pharmaceutical Labs Handling OOS results

What’s your SOP when an out-of-specification result is observed during QC?

Immediate action: quarantine product and inform QA.

Root cause analysis (RCA) is key. Use fishbone diagrams.

Always confirm result with repeat test—avoid re-testing blindly.

Re-testing must be scientifically justified, not used to invalidate results.

We use CAPA (Corrective and Preventive Action) tracking for all OOS.

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