SOP: Investigation of Out of Specification (OOS) Analysis Results

This SOP: Investigation of Out of Specification (OOS) Analysis Results defines the procedure for identifying, assessing, and documenting OOS findings from production or laboratory testing. It ensures scientifically sound investigations, regulatory compliance, and robust data integrity when results fall outside established specifications.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed to meet EU/FDA expectations for OOS handling, the template outlines responsibilities, laboratory checks, retesting vs. resampling, decision-making criteria, failure investigation requirements, and documentation rules — including when OOS triggers deviations.
 
Includes:
• Definition and types of OOS results
• Laboratory assessment and root cause investigation
• Retesting, resampling, and decision tree for batch disposition
• Requirements for documentation, approvals, and CAPA
• Rules for invalidating data and handling suspect results
• Guidance for outsourced testing at GMP contractors
 
Why it matters:
OOS handling is a major focus area during GMP inspections. This SOP ensures your organisation follows a structured, defensible process that protects product quality, supports accurate decision-making, and satisfies regulatory expectations.