ensures compliance with labeling standards, while the QC Manager oversees sampling and testing of quarantined materials.

5. Procedure

5.1 Quarantine Area Setup

1. Designation of Quarantine Area:
   • Assign a dedicated, clearly marked area for quarantined materials, separate from approved and rejected materials.
   • Ensure proper environmental controls (temperature, humidity) to protect material integrity.
2. Access Control:
   • Restrict access to authorized personnel only and maintain an entry log for the quarantine area.
   • Post clear signage indicating “QUARANTINE AREA – AUTHORIZED PERSONNEL ONLY.”

5.2 Labeling of Raw Materials in Quarantine

1. Labeling Requirements:
   • Each quarantined material must be labeled with:
     • “UNDER TEST” or “QUARANTINE” status.
     • Material name and code.
     • Batch/Lot number.
     • Supplier name.
     • Date of receipt.
     • Assigned Goods Receipt Note (GRN) number.
   • Use color-coded labels for easy identification:
     • Yellow: Under Test.
     • Red: Rejected.
     • Green: Approved (post-testing).
   • Document all labeling details in the Quarantine Labeling Log (Annexure-1).

5.3 Segregation of Raw Materials in Quarantine

1. Segregation by Material Type:
   • Segregate materials based on type (e.g., APIs, excipients, solvents) to prevent cross-contamination.
   • Store hazardous or temperature-sensitive materials in designated areas with appropriate controls.
2. Segregation by Testing Status:
   • Separate materials awaiting testing from those with completed testing but pending QA approval.
   • Clearly mark areas for materials under test and materials pending disposition.
   • Document segregation details in the Quarantine Segregation Log (Annexure-2).

5.4 Handling of Quarantined Materials

1. Material Movement:
   • Do not move quarantined materials out of the quarantine area without QA authorization.
   • Record all material movements in the Quarantine Movement Log (Annexure-3).
2. Sampling Procedures:
   • QC personnel must follow standard sampling procedures in designated sampling zones within the quarantine area.
   • Record sampling activities in the Quarantine Sampling Log (Annexure-4).

5.5 Final Disposition of Quarantined Materials

1. Approval or Rejection:
   • QA reviews test results and inspection reports to approve or reject materials.
   • Update labels to reflect final status and move materials to approved or rejected storage areas accordingly.
   • Document final disposition in the Quarantine Disposition Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• QC: Quality Control
• GRN: Goods Receipt Note

7. Documents

1. Quarantine Labeling Log (Annexure-1)
2. Quarantine Segregation Log (Annexure-2)
3. Quarantine Movement Log (Annexure-3)
4. Quarantine Sampling Log (Annexure-4)
5. Quarantine Disposition Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Quarantine Labeling Log

Date	Material Name	Batch Number	Label Status	GRN Number	Labeled By	Remarks
01/02/2025	API-X	X-2025-001	Under Test	GRN-1001	Ravi Kumar	Awaiting QC Sampling
01/02/2025	Excipient-Y	Y-2025-002	Under Test	GRN-1002	Sunita Sharma	Pending Documentation Verification

Annexure-2: Quarantine Segregation Log

Date	Material Name	Batch Number	Segregation Type	Location	Segregated By	Remarks
01/02/2025	API-X	X-2025-001	APIs	Quarantine Zone A	Anil Mehta	Properly Separated from Excipients

Annexure-3: Quarantine Movement Log

Date	Material Name	Batch Number	From	To	Moved By	Authorized By
02/02/2025	API-X	X-2025-001	Quarantine Zone A	QC Sampling Area	Ajay Singh	Anjali Mehta (QA)

Annexure-4: Quarantine Sampling Log

Date	Material Name	Batch Number	Sampled By	Test Type	Remarks
02/02/2025	API-X	X-2025-001	Priya Desai	Identity and Purity	Results Pending

Annexure-5: Quarantine Disposition Log

Date	Material Name	Batch Number	Disposition	Approved By	Remarks
03/02/2025	API-X	X-2025-001	Approved	Anjali Mehta	Ready for Use
03/02/2025	Excipient-Y	Y-2025-002	Rejected	Anjali Mehta	Failed Identity Test

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	Enhanced Segregation and Labeling Procedures	Compliance Improvement	QA Head