Standard Operating Procedure for Handling of Quarantined Materials in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/004/2025
Supersedes	SOP/API/004/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for the proper handling, storage, identification, segregation, and control of raw materials under quarantine status, ensuring that untested or unapproved materials are not used in production and are maintained under GMP-compliant conditions until disposition.

2. Scope

This SOP applies to all raw materials received at the API manufacturing warehouse which are pending quality control sampling, testing, and final disposition by the Quality Assurance department.

3. Responsibilities

• Warehouse Staff: Ensure proper labeling, storage, and control of quarantined materials.
• Quality Control (QC): Collect samples from quarantined stock for analysis.
• Quality Assurance (QA): Review test results and update the status to “Approved” or “Rejected.”

4. Accountability

The Warehouse Manager and QA Manager are jointly accountable for ensuring that no quarantined material is used before approval, and that all such materials are clearly segregated and tracked.

5. Procedure

5.1 Definition of Quarantine

1. All materials received into the warehouse which have not yet been sampled, tested, or approved are considered under “Quarantine.”
2. Such materials are physically and logically segregated and must be identified with a red “Quarantine” status tag.

5.2 Quarantine Area Control

1. Establish a dedicated quarantine area with physical demarcation (barriers or painted boundaries).
2. Ensure quarantine storage areas are:
   • Clearly labeled and access-controlled
   • Separate from released and rejected materials
   • Clean and pest-free
3. Store materials by batch and supplier to avoid mix-ups.
4. Temperature and humidity must be monitored and recorded as per SOP/API/018/2025.

5.3 Labeling of Quarantined Materials

1. Each container under quarantine shall carry a red-colored “QUARANTINE” label with the following details:
   • Material Name
   • Batch Number
   • Quantity
   • Supplier Name
   • Date of Receipt
   • Received By
2. Labels must be clean, intact, legible, and securely affixed to the outermost container.

5.4 Access Control and Movement Restrictions

1. No material under quarantine shall be moved out of the quarantine area without documented QA approval.
2. Warehouse staff must maintain the “Quarantine Movement Log” (Annexure-1) for any internal relocations.
3. Any accidental or unauthorized removal of material must be reported as a deviation and investigated.

5.5 Sampling and Testing

1. After QA clearance, QC will sample the quarantined material as per SOP/API/003/2025.
2. Sampling must be recorded in the “Sampling Authorization Form” (Annexure-2).
3. Post-sampling, the container must be resealed and the “Sampled” label affixed beside the quarantine tag.

5.6 Final Disposition

1. Upon receiving test results, QA will:
   • Replace the red tag with a green “APPROVED” label if results meet specifications
   • Replace the red tag with a yellow “REJECTED” label if the batch fails to meet specifications
2. All status changes must be recorded in the “Material Status Log” (Annexure-3).
3. Approved materials are shifted to the released area; rejected materials to the rejection area, and a rejection report is initiated.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient

7. Documents

1. Quarantine Movement Log (Annexure-1)
2. Sampling Authorization Form (Annexure-2)
3. Material Status Log (Annexure-3)

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211.80
• WHO TRS No. 986 Annex 2

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rajesh Kumar	Sunita Reddy	Manoj Verma
Designation	Warehouse Officer	QA Executive	QA Manager
Department	API Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Quarantine Movement Log

Date	Material	Batch	Moved From	Moved To	Authorized By
13/04/2025	Citric Acid	CA20250413	Receiving Bay	Quarantine Area	Sunita Reddy

Annexure-2: Sampling Authorization Form

Date	Material	Batch	Approved By (QA)	Sampled By (QC)
13/04/2025	Citric Acid	CA20250413	Sunita Reddy	Rajesh Kumar

Annexure-3: Material Status Log

Date	Material	Batch	Previous Status	New Status	Updated By
14/04/2025	Citric Acid	CA20250413	Quarantine	Approved	Manoj Verma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial SOP release	New process documentation	QA Head
13/04/2025	2.0	Included status log and movement controls	Process enhancement	QA Head