to the manufacturing process, which may assist in the investigation of OOS results. The team may need to implement corrective actions to prevent future occurrences.

Management Team: Responsible for reviewing and approving final investigation reports, ensuring that appropriate actions are taken to prevent recurrence of OOS results.

4. Accountability

The QC Manager is accountable for ensuring that OOS results are identified, reported, and investigated in a timely manner. The QA Manager is responsible for overseeing the investigation process, ensuring compliance with GMP, and approving final investigation reports and corrective actions. The Production Manager is responsible for implementing corrective actions within the production process.

5. Procedure

5.1 Identifying and Reporting OOS Results

1. QC personnel must immediately report any test results that fall outside the specified limits to the QC Manager and the QA Team.
2. The OOS result should be recorded in the OOS Log (Annexure-1), including the test type, sample details, test date, result, and the specification limits.
3. The individual responsible for the test must sign off on the OOS result to confirm the observation and initiate the reporting process.

5.2 Investigating OOS Results

1. Upon identifying an OOS result, an investigation should be initiated to determine whether the OOS was due to testing error, equipment malfunction, or an actual deviation in the product quality.
2. Investigate the following potential causes:
   • Sampling errors
   • Instrument malfunction or improper calibration
   • Operator errors during testing
   • Deviations in the manufacturing process (e.g., ingredient addition, mixing, storage conditions)
   • Issues with raw materials or packaging components
3. The investigation should include a review of batch records, equipment calibration logs, and testing procedures to identify any discrepancies or anomalies.
4. Document the investigation process, including the root cause analysis, in the OOS Investigation Report (Annexure-2).

5.3 Corrective and Preventive Actions (CAPA)

1. Once the root cause of the OOS result has been identified, the appropriate corrective actions must be implemented to resolve the issue and prevent recurrence.
2. Corrective actions may include:
   • Re-running the test with a new sample or re-sampling the product
   • Calibrating or repairing equipment
   • Retraining personnel on testing procedures
   • Adjusting the manufacturing process if needed
3. Preventive actions should also be taken to address any systemic issues, such as revising SOPs, improving quality checks, or enhancing training programs.
4. Document all corrective and preventive actions in the CAPA Log (Annexure-3). Ensure that each action is tracked for completion and effectiveness.

5.4 Final Review and Reporting

1. Once the investigation is completed, and corrective and preventive actions have been implemented, the investigation report and CAPA should be reviewed by the QA Manager and senior management.
2. If the OOS result is determined to be valid, the product batch in question should be re-assessed to determine whether it can be released for distribution or requires rework or rejection.
3. Document the final decision regarding the OOS result, including the product status and any actions taken, in the Final OOS Report (Annexure-4).
4. Ensure that all documentation is retained for a minimum of two years or as required by regulatory guidelines.

5.5 Documentation and Record-Keeping

1. Ensure that all OOS results, investigations, CAPAs, and final reports are properly documented and securely stored. These records include the OOS Log (Annexure-1), OOS Investigation Report (Annexure-2), CAPA Log (Annexure-3), and Final OOS Report (Annexure-4).
2. Retain all records for the required duration as per regulatory guidelines (typically two years or as required by local regulations).
3. Ensure that records are reviewed and approved by the Quality Assurance team to ensure compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• OOS: Out-of-Specification
• CAPA: Corrective and Preventive Actions

7. Documents

1. Annexure-1: OOS Log
2. Annexure-2: OOS Investigation Report
3. Annexure-3: CAPA Log
4. Annexure-4: Final OOS Report

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Investigating Out-of-Specification Results

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: OOS Log

Batch Number	Test Type	Test Date	OOS Result	Specification	Operator
12345	Viscosity	21/01/2026	Out of Range	50-100 cP	John Doe

Annexure-2: OOS Investigation Report

Batch Number	Investigation Date	Root Cause	Corrective Action	Operator
12345	22/01/2026	Equipment calibration error	Recalibrated equipment and retested	Jane Smith

Annexure-3: CAPA Log

CAPA ID	Action Date	Corrective Action Taken	Preventive Action Taken	Follow-Up Date
CAPA-001	23/01/2026	Recalibrated viscometer	Revised calibration procedure	26/01/2026

Annexure-4: Final OOS Report

Batch Number	Final Decision	Action Taken	Approved By
12345	Pass after recalibration	Recalibrated and retested	QA Head

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head