Standard Operating Procedure for Reviewing Material Release or Rejection Decisions from Quarantine
Department | Quality Assurance / Quality Control / Warehouse |
---|---|
SOP No. | SOP/RM/089/2025 |
Supersedes | SOP/RM/089/2022 |
Page No. | Page 1 of 15 |
Issue Date | 01/02/2025 |
Effective Date | 05/02/2025 |
Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for reviewing and approving decisions related to the release or rejection of raw materials from quarantine. It ensures that decisions are based on validated test results, regulatory compliance, and quality standards.
2. Scope
This SOP applies to all raw materials stored in quarantine, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, ensuring their proper release for use in manufacturing or rejection for disposal.
3. Responsibilities
- Quality Assurance (QA): Review test results, verify compliance with specifications, and approve or reject materials.
- Quality Control (QC): Conduct necessary tests on quarantined materials and document results accurately.
- Warehouse Personnel: Ensure proper labeling and segregation of materials awaiting release or rejection decisions.
4. Accountability
The QA Manager is accountable for ensuring that all material release and rejection decisions comply with regulatory standards and company procedures. The QC Manager is responsible for providing
5. Procedure
5.1 Initial Review of Test Results
- 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.
- 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
- Conformance to Specifications:
- Materials must meet all physical, chemical, and microbiological specifications as per the approved material specification document.
- Regulatory Compliance:
- Ensure that the material complies with applicable regulatory guidelines, such as ICH, WHO, and local regulatory authorities.
- Documentation Verification:
- Verify that all required documents, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and supplier certificates, are complete and accurate.
- 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
- Non-Conformance to Specifications:
- Materials that fail to meet specified criteria in any test parameter will be rejected.
- Contamination or Damage:
- Materials showing signs of contamination, physical damage, or tampering will be rejected.
- Incomplete Documentation:
- Materials without proper documentation, including missing CoA or MSDS, will not be released and may be rejected.
- 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
- Identification and Documentation:
- All OOS results must be documented in the OOS Report (Annexure-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).
- Decision Based on Investigation:
- Based on investigation findings, QA will decide whether to release or reject the material.
5.5 Documentation and Record-Keeping
- Material Release Documentation:
- Maintain complete records of all released materials, including test results, approval forms, and regulatory compliance documents.
- 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
- Personnel Training:
- All QA and QC personnel must be trained in material release and rejection procedures.
- Document training in the Training Log (Annexure-8).
- 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
- QC Test Result Log (Annexure-1)
- OOS Report (Annexure-2)
- Material Release Authorization Form (Annexure-3)
- Quarantine Release Log (Annexure-4)
- Material Rejection Authorization Form (Annexure-5)
- Quarantine Rejection Log (Annexure-6)
- OOS Investigation Report (Annexure-7)
- Training Log (Annexure-8)
- 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 |