accurate test data to support these decisions.

5. Procedure

5.1 Initial Review of Test Results

1. Collection of Test Results:
   • QC personnel conduct all required tests on quarantined materials and document results in the QC Test Result Log (Annexure-1).
   • Results must be reviewed for accuracy and completeness before submission to QA.
2. Preliminary Assessment by QA:
   • QA reviews test results for conformance with material specifications.
   • Any discrepancies or out-of-specification (OOS) results must be documented and investigated (Annexure-2).

5.2 Criteria for Material Release

1. Conformance to Specifications:
   • Materials must meet all physical, chemical, and microbiological specifications as per the approved material specification document.
2. Regulatory Compliance:
   • Ensure that the material complies with applicable regulatory guidelines, such as ICH, WHO, and local regulatory authorities.
3. Documentation Verification:
   • Verify that all required documents, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and supplier certificates, are complete and accurate.
4. Approval of Release:
   • QA signs off on the Material Release Authorization Form (Annexure-3).
   • Update the Quarantine Release Log with the release decision (Annexure-4).

5.3 Criteria for Material Rejection

1. Non-Conformance to Specifications:
   • Materials that fail to meet specified criteria in any test parameter will be rejected.
2. Contamination or Damage:
   • Materials showing signs of contamination, physical damage, or tampering will be rejected.
3. Incomplete Documentation:
   • Materials without proper documentation, including missing CoA or MSDS, will not be released and may be rejected.
4. Approval of Rejection:
   • QA documents the rejection decision in the Material Rejection Authorization Form (Annexure-5).
   • Update the Quarantine Rejection Log with the rejection decision (Annexure-6).

5.4 Investigation of Out-of-Specification (OOS) Results

1. Identification and Documentation:
   • All OOS results must be documented in the OOS Report (Annexure-2).
2. Root Cause Analysis:
   • Conduct a thorough investigation to determine the cause of the OOS result, including re-testing if applicable.
   • Document the investigation in the OOS Investigation Report (Annexure-7).
3. Decision Based on Investigation:
   • Based on investigation findings, QA will decide whether to release or reject the material.

5.5 Documentation and Record-Keeping

1. Material Release Documentation:
   • Maintain complete records of all released materials, including test results, approval forms, and regulatory compliance documents.
2. Material Rejection Documentation:
   • Maintain detailed records of all rejected materials, including reasons for rejection, investigation reports, and disposal plans.

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All QA and QC personnel must be trained in material release and rejection procedures.
   • Document training in the Training Log (Annexure-8).
2. Compliance Audits:
   • QA conducts periodic audits of release and rejection processes to ensure compliance with SOP and regulatory standards.
   • Document audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

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

7. Documents

1. QC Test Result Log (Annexure-1)
2. OOS Report (Annexure-2)
3. Material Release Authorization Form (Annexure-3)
4. Quarantine Release Log (Annexure-4)
5. Material Rejection Authorization Form (Annexure-5)
6. Quarantine Rejection Log (Annexure-6)
7. OOS Investigation Report (Annexure-7)
8. Training Log (Annexure-8)
9. Compliance Audit 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 Test Result Log

Date	Material Name	Batch Number	Test Conducted	Result	Tested By
01/02/2025	API-X	API-X-2025-001	Purity Test	98%	Sunita Sharma

Annexure-2: OOS Report

Date	Material Name	Batch Number	Description of OOS	Reported By
02/02/2025	API-X	API-X-2025-001	Purity Below Specification	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 Authorization Form

Date	Material Name	Batch Number	Rejected By	Reason for Rejection
04/02/2025	API-X	API-X-2025-001	Anjali Mehta	Purity Below Specification

Annexure-6: Quarantine Rejection Log

Date	Material Name	Batch Number	Rejection Decision	Rejected By
04/02/2025	API-X	API-X-2025-001	Rejected	QA Manager

Annexure-7: OOS Investigation Report

Date	Material Name	Batch Number	Investigation Findings	Conclusion
05/02/2025	API-X	API-X-2025-001	Supplier Process Issue Identified	Material Rejected

Annexure-8: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
06/02/2025	Material Release and Rejection Procedures	QA Manager	Sunita Sharma

Annexure-9: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
07/02/2025	Material Release Compliance Audit	Documentation Gaps Found	Updated SOP for Documentation Accuracy	Anjali Mehta

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 Material Release and Rejection Procedures	Regulatory Compliance	QA Head