is accountable for the release or rejection of quarantined materials, ensuring that all processes comply with regulatory requirements. The Warehouse Manager is responsible for the proper storage and handling of materials and maintaining accurate records.

5. Procedure

5.1 Material Receipt and Quarantine Placement

1. Receiving Raw 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).
2. Quarantine Labeling and Storage:
   • All materials must be labeled with a “QUARANTINE” tag, including:
     • Material Name
     • Batch/Lot Number
     • Date of Receipt
     • Supplier Information
   • Store quarantined materials in designated quarantine storage areas, separate from approved or rejected materials.
   • Document the storage location in the Quarantine Material Log (Annexure-2).

5.2 Sampling and Testing Coordination

1. QA Authorization for Sampling:
   • QA will authorize sampling by completing the Sampling Authorization Form (Annexure-3).
   • Warehouse will coordinate with QC to facilitate the sampling process.
2. QC Sampling and Testing:
   • QC will collect samples and conduct required tests as per standard protocols.
   • Record sampling details in the Quarantine Sampling Log (Annexure-4).
3. Communication of Results:
   • QC will submit test results to QA for review.
   • QA will communicate approval or rejection decisions to the Warehouse team for further action.

5.3 Material Release or Rejection Process

1. Material Release Procedure:
   • Upon approval, QA will complete 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).
2. Material Rejection Procedure:
   • For rejected materials, QA will complete the Material Rejection Form (Annexure-7).
   • Warehouse will move rejected materials to the designated rejection area and update the Rejected Material Log (Annexure-8).

5.4 Regular Communication and Review

1. Weekly Coordination Meetings:
   • QA and Warehouse teams will conduct weekly meetings to review the status of quarantined materials, pending test results, and any issues in the quarantine process.
   • Document meeting outcomes in the Quarantine Coordination Meeting Log (Annexure-9).
2. Review of Quarantine Records:
   • QA will perform periodic reviews of quarantine records to ensure compliance and accuracy.
   • Document findings in the Quarantine Record Review Log (Annexure-10).

5.5 Documentation and Record-Keeping

1. Record Maintenance:
   • All records related to quarantine management must be maintained in compliance with regulatory requirements.
   • Ensure all documentation is reviewed and archived appropriately in the Quarantine Record Archive (Annexure-11).

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All QA and Warehouse personnel must receive training on quarantine procedures, documentation, and regulatory compliance.
   • Document training sessions in the Training Log (Annexure-12).
2. Compliance Audits:
   • QA will conduct periodic audits of quarantine management processes to ensure ongoing compliance.
   • Document 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

1. Raw Material Receiving Log (Annexure-1)
2. Quarantine Material Log (Annexure-2)
3. Sampling Authorization Form (Annexure-3)
4. Quarantine Sampling Log (Annexure-4)
5. Material Release Authorization Form (Annexure-5)
6. Quarantine Release Log (Annexure-6)
7. Material Rejection Form (Annexure-7)
8. Rejected Material Log (Annexure-8)
9. Quarantine Coordination Meeting Log (Annexure-9)
10. Quarantine Record Review Log (Annexure-10)
11. Quarantine Record Archive (Annexure-11)
12. Training Log (Annexure-12)
13. 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	Meeting 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

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 GMP Compliance Procedures	Regulatory Compliance	QA Head