Standard Operating Procedure for Segregation of Approved, Rejected, and Quarantined Raw Materials

Department	Warehouse / Quality Assurance
SOP No.	SOP/RM/103/2025
Supersedes	SOP/RM/103/2022
Page No.	Page 1 of 15
Issue Date	03/02/2025
Effective Date	07/02/2025
Review Date	03/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for segregating approved, rejected, and quarantined raw materials in the warehouse to prevent cross-contamination, ensure material integrity, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals. It covers procedures for physical segregation, labeling, documentation, and handling of different material statuses.

3. Responsibilities

• Warehouse Personnel: Ensure proper segregation, labeling, and storage of approved, rejected, and quarantined raw materials. Maintain accurate records of material status.
• Quality Assurance (QA): Oversee segregation practices, verify compliance with GMP guidelines, and conduct periodic audits.
• Warehouse Manager: Ensure staff adherence to segregation procedures and address any discrepancies.

4. Accountability

The Warehouse Manager is accountable for implementing and maintaining segregation practices. The QA Manager is responsible for verifying compliance with GMP requirements through audits and documentation reviews.

5. Procedure

5.1 Material Status Classification

1. Approved Materials:
   • Materials that have passed quality control testing and are cleared for use in production.
   • Labeled with green tags indicating “APPROVED.”
2. Quarantined Materials:
   • Materials awaiting quality control testing or under investigation.
   • Labeled with yellow tags indicating “QUARANTINE.”
3. Rejected Materials:
   • Materials that have failed quality control testing or do not meet specifications.
   • Labeled with red tags indicating “REJECTED.”

5.2 Segregation of Materials

1. Physical Segregation:
   • Store approved, quarantined, and rejected materials in clearly marked, physically separated areas within the warehouse.
   • Use barriers, color-coded floor markings, or dedicated rooms to prevent mix-ups.
2. Environmental Controls:
   • Ensure that segregated areas maintain appropriate temperature, humidity, and other environmental conditions as required.
   • Document environmental conditions in the Storage Conditions Log (Annexure-1).

5.3 Labeling and Documentation

1. Labeling Requirements:
   • All materials must be clearly labeled with:
     • Material Name
     • Batch Number
     • Status (Approved, Quarantine, Rejected)
     • Storage Conditions (if applicable)
   • Document labeling activities in the Labeling Log (Annexure-2).
2. Status Change Documentation:
   • Any change in material status (e.g., from Quarantine to Approved) must be documented in the Status Change Log (Annexure-3).
   • QA approval is required for all status changes.

5.4 Handling of Rejected Materials

1. Storage of Rejected Materials:
   • Store rejected materials in a separate, secure area labeled “REJECTED MATERIALS.”
   • Ensure rejected materials are not accessible for production use.
2. Disposal of Rejected Materials:
   • Coordinate with QA and Environmental Health & Safety (EHS) teams for proper disposal of rejected materials.
   • Document disposal activities in the Rejected Material Disposal Log (Annexure-4).

5.5 Periodic Review and Compliance Monitoring

1. Warehouse Inspections:
   • Conduct regular inspections to ensure proper segregation and labeling of materials.
   • Record inspection findings in the Warehouse Inspection Log (Annexure-5).
2. QA Compliance Audits:
   • QA will conduct periodic audits to verify compliance with segregation procedures.
   • Document audit findings in the Compliance Audit Log (Annexure-6).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• EHS: Environmental Health & Safety

7. Documents

1. Storage Conditions Log (Annexure-1)
2. Labeling Log (Annexure-2)
3. Status Change Log (Annexure-3)
4. Rejected Material Disposal Log (Annexure-4)
5. Warehouse Inspection Log (Annexure-5)
6. Compliance Audit Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Storage Conditions Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Recorded By
03/02/2025	Approved Materials Area	22°C	45%	Ravi Kumar

Annexure-2: Labeling Log

Date	Material Name	Batch Number	Status	Labeled By
03/02/2025	API-X	API-X-2025-001	Approved	Sunita Sharma

Annexure-3: Status Change Log

Date	Material Name	Batch Number	Previous Status	New Status	Approved By
04/02/2025	Excipent-Y	EX-Y-2024-002	Quarantine	Approved	Anjali Mehta

Annexure-4: Rejected Material Disposal Log

Date	Material Name	Batch Number	Disposal Method	Disposed By
05/02/2025	API-Y	API-Y-2025-003	Incineration	Ravi Kumar

Annexure-5: Warehouse Inspection Log

Date	Area Inspected	Inspector	Findings	Corrective Actions
06/02/2025	Quarantine Area	Anjali Mehta	No issues found	N/A

Annexure-6: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
07/02/2025	Segregation Compliance Audit	All procedures compliant	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
03/02/2025	2.0	Updated Segregation Procedures and Documentation Formats	Regulatory Compliance	QA Head