1. Purpose
- To define the procedure for investigating and resolving Out-of-Specification (OOS) results encountered during the testing of pharmaceutical products or raw materials.
2. Scope
- This SOP applies to all personnel involved in the testing, documentation, and reporting of analytical results in pharmaceutical manufacturing facilities.
3. Responsibilities
- Quality Assurance (QA):
- Oversees the overall OOS investigation process.
- Ensures compliance with regulatory requirements and company policies.
- Quality Control (QC):
- Conducts initial investigation of OOS results.
- Implements corrective actions as necessary.
- Production Department:
- Provides necessary support and information during investigations.
- Implements any production-related corrective actions identified.
4. Definitions
- Out-of-Specification (OOS): Test result that falls outside the established acceptance criteria.
- Root Cause Analysis (RCA): Methodical process for determining the underlying reason(s) for an OOS result.
5. Procedure 5.1 Notification of OOS Result
- Upon identification of an OOS result, QC personnel immediately notify the QA department.
- Document the OOS result, including test details, equipment used, and any observations made during testing.
5.2 Initial Investigation
- QC personnel conduct a preliminary investigation to determine if the OOS result is valid or attributable to laboratory error.
- Check for potential errors in sample preparation, testing procedures, or equipment malfunction.
- If the OOS result is determined to be valid, proceed to a formal investigation.
5.3 Formal Investigation
- QA initiates a formal investigation into the OOS result following the documented procedures.
- Assemble a team comprising QC, QA, and subject matter experts as necessary.
- Perform a comprehensive review of all relevant documentation, including batch records, calibration logs, and previous testing data.
- Conduct a thorough root cause analysis (RCA) to identify the underlying reason(s) for the OOS result.
- Determine the impact of the OOS result on product quality, safety, and compliance.
5.4 Corrective and Preventive Actions (CAPA)
- Develop and implement appropriate corrective actions to address the identified root cause(s) of the OOS result.
- Implement preventive measures to prevent recurrence of similar incidents in the future.
- Document all CAPA activities, including timelines and responsible personnel.
5.5 Documentation and Reporting
- Maintain detailed records of the OOS investigation, including all findings, actions taken, and conclusions reached.
- Prepare a formal OOS investigation report summarizing the investigation process, results, and outcomes.
- Submit the report to QA for review and approval before finalizing.
6. Records and Documentation
- All records related to OOS investigations, including laboratory data, investigation reports, and CAPA documentation, must be maintained in compliance with regulatory requirements and company policies.
7. Training
- Ensure that all personnel involved in OOS investigations receive appropriate training on the procedures outlined in this SOP.
- Provide regular refresher training to reinforce knowledge and skills related to OOS investigations.
8. Review and Revision
- Periodically review and revise this SOP as necessary to ensure it remains current and effective.
- Any revisions must be approved by QA before implementation.
9. References
- List any relevant regulatory guidelines, industry standards, or internal procedures referenced in this SOP.
10. Approval
- This SOP is approved by [Name and Title of Approving Authority] and is effective from [Effective Date]. Any subsequent revisions must be approved as per company policy.
11. Appendix
- Include any additional forms, templates, or supporting documents relevant to the implementation of this SOP.
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