1) SOP for OOS Investigations

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the steps for investigating and addressing test results that fall outside established specifications (Out of Specification or OOS results) in the pharmaceutical industry.

3) Scope

This SOP applies to all laboratory personnel, quality control (QC) analysts, and quality assurance (QA) personnel involved in testing and releasing pharmaceutical products.

4) Responsibilities

• QC Analysts: Responsible for initial identification and documentation of OOS results.
• QA Personnel: Responsible for reviewing and approving the investigation and ensuring compliance with regulatory requirements.
• Laboratory Supervisors: Responsible for overseeing the investigation process and ensuring timely completion.
• Production Personnel: May be involved in the investigation if the OOS results are related to production issues.

5) Procedure

1. Identification of OOS Results
   1. QC analysts identify and document any test results that fall outside established specifications.
   2. Immediately notify the laboratory supervisor and QA department of the OOS result.
   3. Quarantine the affected batch or product pending investigation.
2. Initial Laboratory Investigation
   1. Review the test method, calculations, and equipment used to ensure there were no errors or deviations.
   2. Recheck the raw data and calculations for accuracy.
   3. If an error is identified, document the findings and correct the error. Retest the sample if necessary.
   4. If no error is identified, proceed with a thorough investigation.
3. Full Investigation
   1. Form an investigation team consisting of QC, QA, and other relevant personnel.
   2. Collect and review all relevant data, including batch records, raw material specifications, and test methods.
   3. Evaluate potential sources of variability, such as equipment performance, environmental conditions, and operator technique.
   4. Perform retesting on retained samples and additional samples if available. Document all retesting activities.
4. Root Cause Analysis
   1. Analyze the data collected to identify potential root causes of the OOS result.
   2. Use root cause analysis tools such as fishbone diagrams, Pareto analysis, and process mapping.
   3. Document the identified root cause(s) and any contributing factors.
5. Corrective and Preventive Actions (CAPA)
   1. Develop and implement a CAPA plan based on the findings of the root cause analysis.
   2. Ensure the CAPA plan addresses both the immediate issue and any underlying systemic problems.
   3. Assign responsibilities and timelines for the implementation of CAPA.
   4. Monitor and verify the effectiveness of the CAPA plan through follow-up testing and inspections.
6. Documentation and Reporting
   1. Ensure all steps of the investigation, findings, and CAPA actions are thoroughly documented.
   2. Prepare a detailed investigation report and submit it to the QA department for review and approval.
   3. Maintain records of the investigation and CAPA actions for future reference and regulatory audits.
7. Communication
   1. Communicate the findings of the OOS investigation and the implemented CAPA to all relevant departments.
   2. Provide training or updates to personnel if the investigation identifies changes in procedures or practices.

6) Abbreviations, if any

• OOS: Out of Specification
• QC: Quality Control
• QA: Quality Assurance
• CAPA: Corrective and Preventive Actions
• SOP: Standard Operating Procedure

7) Documents, if any

• OOS Investigation Forms
• Laboratory Test Records
• Batch Records
• CAPA Documentation
• Investigation Reports

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• Company-specific quality management policies

9) SOP Version

Version 1.0