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

1. 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).
2. 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

1. 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.
2. 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).
3. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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

1. 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).
2. 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

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	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