Standard Operating Procedure (SOP) for Out-of-Specification (OOS) Investigations

Standard Operating Procedure (SOP) for Out-of-Specification (OOS) Investigations

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.

Leave a Comment

Your email address will not be published. Required fields are marked *

Hk$0 placement fees for direct hire.