Standard Operating Procedure for Coordination Between QA and Warehouse Teams for Quarantine Management
Department | Quality Assurance / Warehouse |
---|---|
SOP No. | SOP/RM/096/2025 |
Supersedes | SOP/RM/096/2022 |
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 effective coordination between the Quality Assurance (QA) and Warehouse teams for the management of quarantined raw materials. It outlines responsibilities, communication protocols, and procedures to ensure the proper handling, storage, documentation, and release of quarantined materials.
2. Scope
This SOP applies to all raw materials received at the facility that are placed in quarantine pending quality testing and approval. It encompasses the activities from material receipt, labeling, and sampling to testing, release, or rejection.
3. Responsibilities
- Warehouse Personnel: Receive, inspect, label, and store quarantined raw materials. Maintain accurate records and coordinate with QA and QC for sampling and testing.
- Quality Assurance (QA): Authorize sampling, review test results, approve material release or rejection, and ensure compliance with GMP guidelines.
- Quality Control (QC): Conduct sampling and testing of quarantined materials and communicate results to QA and Warehouse teams.
4. Accountability
The
QA Manager is accountable for ensuring compliance with quarantine procedures and GMP standards. The Warehouse Manager is responsible for the proper storage and handling of quarantined materials, ensuring that all documentation is accurate and complete.
5. Procedure
5.1 Receipt and Initial Handling of Raw Materials
- Receiving Materials:
- Warehouse personnel will receive raw materials, verify shipment details against purchase orders, and inspect for damages.
- Record material details in the Raw Material Receiving Log (Annexure-1).
- Quarantine Labeling and Storage:
- Label all materials with a “QUARANTINE” tag that includes the material name, batch number, receipt date, and supplier details.
- Store materials in designated quarantine areas, separate from approved or rejected materials.
- Update the Quarantine Material Log (Annexure-2) with storage location and material details.
5.2 Coordination for Sampling and Testing
- Authorization for Sampling:
- QA will authorize sampling by completing the Sampling Authorization Form (Annexure-3).
- Warehouse personnel will coordinate with QC to facilitate the sampling process.
- QC Sampling and Testing:
- QC will collect samples as per standard protocols and conduct required tests.
- Document sampling and testing details in the Quarantine Sampling Log (Annexure-4).
- Communication of Results:
- QC will submit test results to QA for review.
- QA will communicate approval or rejection decisions to the Warehouse for further action.
5.3 Material Release or Rejection Process
- Material Release Procedure:
- QA will approve materials that pass testing by completing the Material Release Authorization Form (Annexure-5).
- Warehouse personnel will move released materials to the approved storage area and update the Quarantine Release Log (Annexure-6).
- Material Rejection Procedure:
- QA will document rejected materials using the Material Rejection Form (Annexure-7).
- Warehouse will transfer rejected materials to the designated rejection area and update the Rejected Material Log (Annexure-8).
5.4 Communication and Review Process
- Weekly Coordination Meetings:
- QA and Warehouse teams will conduct weekly meetings to review the status of quarantined materials and address any pending issues.
- Document meeting outcomes in the Quarantine Coordination Meeting Log (Annexure-9).
- Review of Quarantine Records:
- QA will periodically review quarantine records to ensure compliance and accuracy.
- Record findings and corrective actions in the Quarantine Record Review Log (Annexure-10).
5.5 Documentation and Record-Keeping
- Maintaining Records:
- All records related to quarantine management must be maintained accurately and in compliance with GMP guidelines.
- Archive records in the Quarantine Record Archive (Annexure-11) for regulatory review and audits.
5.6 Training and Compliance Monitoring
- Personnel Training:
- All QA and Warehouse personnel must undergo training on quarantine procedures and GMP compliance.
- Document training sessions in the Training Log (Annexure-12).
- Compliance Audits:
- QA will conduct periodic audits to ensure compliance with quarantine management procedures.
- Record audit findings in the Compliance Audit Log (Annexure-13).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- APIs: Active Pharmaceutical Ingredients
7. Documents
- Raw Material Receiving Log (Annexure-1)
- Quarantine Material Log (Annexure-2)
- Sampling Authorization Form (Annexure-3)
- Quarantine Sampling Log (Annexure-4)
- Material Release Authorization Form (Annexure-5)
- Quarantine Release Log (Annexure-6)
- Material Rejection Form (Annexure-7)
- Rejected Material Log (Annexure-8)
- Quarantine Coordination Meeting Log (Annexure-9)
- Quarantine Record Review Log (Annexure-10)
- Quarantine Record Archive (Annexure-11)
- Training Log (Annexure-12)
- Compliance Audit Log (Annexure-13)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Raw Material Receiving Log
Date | Material Name | Batch Number | Supplier | Received By |
---|---|---|---|---|
01/02/2025 | API-X | API-X-2025-001 | Supplier A | Ravi Kumar |
Annexure-2: Quarantine Material Log
Date | Material Name | Batch Number | Quarantine Location | Labeled By |
---|---|---|---|---|
01/02/2025 | API-X | API-X-2025-001 | Quarantine Area 1 | Sunita Sharma |
Annexure-3: Sampling Authorization Form
Date | Material Name | Batch Number | Authorized By | Signature |
---|---|---|---|---|
02/02/2025 | API-X | API-X-2025-001 | Anjali Mehta |
Annexure-4: Quarantine Sampling Log
Date | Material Name | Batch Number | Sampled By | Test Conducted | Result |
---|---|---|---|---|---|
03/02/2025 | API-X | API-X-2025-001 | Ravi Kumar | Purity Test | Pass |
Annexure-5: Material Release Authorization Form
Date | Material Name | Batch Number | Released By | Signature |
---|---|---|---|---|
04/02/2025 | API-X | API-X-2025-001 | Anjali Mehta |
Annexure-6: Quarantine Release Log
Date | Material Name | Batch Number | Released To | Released By |
---|---|---|---|---|
04/02/2025 | API-X | API-X-2025-001 | Production | Anjali Mehta |
Annexure-7: Material Rejection Form
Date | Material Name | Batch Number | Rejected By | Reason for Rejection |
---|---|---|---|---|
05/02/2025 | API-Y | API-Y-2025-002 | Anjali Mehta | Failed Moisture Test |
Annexure-8: Rejected Material Log
Date | Material Name | Batch Number | Rejection Status | Handled By |
---|---|---|---|---|
05/02/2025 | API-Y | API-Y-2025-002 | Moved to Rejection Area | Ravi Kumar |
Annexure-9: Quarantine Coordination Meeting Log
Date | Participants | Discussion Points | Action Items |
---|---|---|---|
06/02/2025 | Anjali Mehta, Ravi Kumar | Review of Pending Quarantine Materials | Follow-up on Testing for API-Z |
Annexure-10: Quarantine Record Review Log
Date | Reviewed By | Findings | Corrective Actions |
---|---|---|---|
07/02/2025 | Anjali Mehta | Minor Documentation Errors | Corrected by Ravi Kumar |
Annexure-11: Quarantine Record Archive
Date | Document Type | Archived By | Location |
---|---|---|---|
08/02/2025 | Quarantine Logs | Ravi Kumar | Archive Room A |
Annexure-12: Training Log
Date | Training Topic | Trainer | Attendee Name | Signature |
---|---|---|---|---|
09/02/2025 | GMP Compliance in Quarantine Management | QA Manager | Sunita Sharma |
Annexure-13: Compliance Audit Log
Date | Audit Type | Findings | Corrective Actions | Audited By |
---|---|---|---|---|
10/02/2025 | Quarantine Compliance Audit | No Major Issues Found | N/A | 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 Coordination Procedures and Documentation Formats | Regulatory Compliance | QA Head |