for overseeing the verification process, ensuring compliance with SOPs, and addressing any discrepancies in test results.

4. Accountability

The QC Manager is accountable for ensuring that test results are verified in a timely and accurate manner. The QA Manager is responsible for ensuring that the results meet regulatory and internal standards. The Laboratory Supervisor ensures proper verification processes and ensures that any discrepancies are addressed according to established protocols.

5. Procedure

5.1 Verification of Initial Test Results

1. Upon completion of testing, the QC team must perform an initial review of the test results to ensure that they are legible, complete, and properly documented.
2. Verify that the test results are within the specified limits outlined in the product’s master specifications or regulatory guidelines.
3. Ensure that all raw data, such as calibration curves, reference standards, and calculation sheets, are appropriately referenced and available for review.
4. Record any discrepancies or deviations observed during testing, such as abnormal readings or errors, and inform the QA team for further investigation.

5.2 QA Review and Verification

1. The QA team must verify the test results within the context of the overall batch history and any related documentation, such as production records, environmental monitoring logs, and equipment calibration records.
2. If the results fall within the specified limits, the QA team should confirm the acceptance of the test results and approve the batch for further processing or release.
3. If the results fall outside of the specified limits, the QA team should initiate an investigation to determine the cause of the discrepancy. This may involve re-testing the sample, checking equipment calibration, or reviewing the production process for potential issues.
4. Document all findings, including approval of results or corrective actions taken, in the Test Results Verification Log (Annexure-1).

5.3 Handling of Out-of-Specification (OOS) Results

1. If the test results are deemed out-of-specification (OOS), initiate an OOS investigation according to the SOP for OOS Results (SOP/CRM/155/2025).
2. Document all steps taken during the OOS investigation, including potential root causes, corrective actions, and the final decision regarding the batch status (e.g., release, rework, or rejection).
3. Once the OOS investigation is complete, the QA team will provide a final report documenting the findings and corrective actions in the OOS Report (Annexure-2).

5.4 Re-Testing and Retesting Procedures

1. If the initial test results are found to be questionable, or if there is a discrepancy in the documentation, re-testing should be performed using a new sample from the batch.
2. Ensure that the re-testing procedure is documented, and the results are reviewed by both QC and QA teams. The re-test should follow the same procedures as the initial testing to maintain consistency and accuracy.
3. If the re-test results are within specification, finalize the results as acceptable, and document the re-test outcome in the Test Results Verification Log (Annexure-1).

5.5 Documentation and Record-Keeping

1. Ensure that all verification processes are fully documented and records are maintained as per GMP guidelines. This includes the Test Results Verification Log (Annexure-1), OOS Report (Annexure-2), and re-testing logs.
2. Ensure that all test result records, including original data, calculations, and final decisions, are securely stored for a minimum of two years or as required by regulatory standards.
3. All records must be available for review during internal audits or regulatory inspections to ensure compliance with GMP standards.

6. Abbreviations

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

7. Documents

1. Annexure-1: Test Results Verification Log
2. Annexure-2: 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: Quality Control Testing and Result Verification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Test Results Verification Log

Batch Number	Test Type	Test Date	Result	Operator	Verified By
12345	Viscosity	21/01/2026	Pass	John Doe	Jane Smith

Annexure-2: OOS Report

Batch Number	Test Type	OOS Date	Investigation Details	Corrective Action	Decision
12345	Viscosity	21/01/2026	Equipment calibration error	Recalibrated equipment	Pass after recalibration

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