documentation.

5. Procedure

5.1 Collection and Preparation of Testing Reports

1. QC Testing Completion:
   • QC personnel complete all required tests as per the approved material specifications.
   • Document test results in the QC Testing Report (Annexure-1) and sign off by the analyst and reviewer.
2. Compilation of Documentation:
   • Ensure the testing report includes:
     • Material Name and Batch/Lot Number
     • Test Methods and Specifications
     • Test Results (Physical, Chemical, Microbiological)
     • Signatures of the Analyst and Reviewer
     • Certificate of Analysis (CoA) from the supplier (if applicable)

5.2 QA Verification of Testing Reports

1. Initial Review:
   • QA reviews the testing report for completeness, accuracy, and adherence to specifications.
   • Verify that all tests required by the material specification sheet have been conducted and results meet acceptance criteria.
2. Cross-Verification:
   • Compare the testing report with the Certificate of Analysis (CoA) from the supplier, if applicable.
   • Check for consistency between supplier data and internal testing results.
3. Review of Deviations or Out-of-Specification (OOS) Results:
   • If any deviations or OOS results are found, document them in the Deviation Log (Annexure-2) and initiate an investigation as per SOP for OOS Handling.

5.3 Approval for Material Release

1. Final Approval:
   • If all results conform to specifications, QA signs the Material Release Authorization Form (Annexure-3).
2. Updating Records:
   • Record the release decision in the Quarantine Release Log (Annexure-4).
   • Communicate the release decision to the warehouse for updating material status.

5.4 Handling of Non-Conforming Materials

1. Rejection Process:
   • If materials fail to meet specifications, QA documents the rejection decision in the Material Rejection Form (Annexure-5).
   • Update the Quarantine Rejection Log (Annexure-6) and communicate the rejection decision to the warehouse.
2. Corrective Actions:
   • Initiate a corrective action process for recurrent non-conformances and document in the Corrective Action Log (Annexure-7).

5.5 Documentation and Record-Keeping

1. Retention of Testing Reports:
   • Maintain all verified testing reports and related documentation for the duration specified in the document retention policy.
2. Audit and Compliance Records:
   • QA conducts periodic audits of the verification process to ensure compliance with SOP and regulatory standards.
   • Document audit findings in the Compliance Audit Log (Annexure-8).

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All QA and QC personnel must be trained in the procedures for verifying testing reports and material release processes.
   • Document training in the Training Log (Annexure-9).
2. Compliance Monitoring:
   • QA regularly monitors compliance with this SOP to ensure ongoing adherence to regulatory and quality standards.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• OOS: Out-of-Specification
• APIs: Active Pharmaceutical Ingredients

7. Documents

1. QC Testing Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Material Release Authorization Form (Annexure-3)
4. Quarantine Release Log (Annexure-4)
5. Material Rejection Form (Annexure-5)
6. Quarantine Rejection Log (Annexure-6)
7. Corrective Action Log (Annexure-7)
8. Compliance Audit Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines for the Pharmaceutical Industry

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: QC Testing Report

Date	Material Name	Batch Number	Test Conducted	Result	Tested By
01/02/2025	API-X	API-X-2025-001	Purity Test	99.2%	Sunita Sharma

Annexure-2: Deviation Log

Date	Material Name	Batch Number	Description of Deviation	Reported By
02/02/2025	API-X	API-X-2025-001	Minor discrepancy in CoA data	Ajay Singh

Annexure-3: Material Release Authorization Form

Date	Material Name	Batch Number	Approved By	Signature
03/02/2025	API-Y	API-Y-2025-002	Anjali Mehta

Annexure-4: Quarantine Release Log

Date	Material Name	Batch Number	Release Decision	Released By
03/02/2025	API-Y	API-Y-2025-002	Released	QA Manager

Annexure-5: Material Rejection Form

Date	Material Name	Batch Number	Rejected By	Reason for Rejection
04/02/2025	API-Z	API-Z-2025-003	Anjali Mehta	Failed Microbial Testing

Annexure-6: Quarantine Rejection Log

Date	Material Name	Batch Number	Rejection Decision	Rejected By
04/02/2025	API-Z	API-Z-2025-003	Rejected	QA Manager

Annexure-7: Corrective Action Log

Date	Non-Conformance Description	Corrective Action	Implemented By	Verified By (QA)
05/02/2025	Discrepancy in CoA Data	Supplier Notified and Corrected CoA Issued	Ajay Singh	Anjali Mehta

Annexure-8: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
06/02/2025	Testing Report Verification Audit	Minor Documentation Errors Found	Revised Documentation Procedures	Anjali Mehta

Annexure-9: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
07/02/2025	Verification of Testing Reports	QA Manager	Sunita Sharma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Testing Verification Procedures for Regulatory Compliance	Regulatory Compliance	QA Head