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
- Approved Materials:
- Materials that have passed quality control testing and are cleared for use in production.
- Labeled with green tags indicating “APPROVED.”
- Quarantined Materials:
- Materials awaiting quality control testing or under investigation.
- Labeled with yellow tags indicating “QUARANTINE.”
- 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
- 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.
- 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
- 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).
- All materials must be clearly labeled with:
- 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
- Storage of Rejected Materials:
- Store rejected materials in a separate, secure area labeled “REJECTED MATERIALS.”
- Ensure rejected materials are not accessible for production use.
- 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
- Warehouse Inspections:
- Conduct regular inspections to ensure proper segregation and labeling of materials.
- Record inspection findings in the Warehouse Inspection Log (Annexure-5).
- 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
- Storage Conditions Log (Annexure-1)
- Labeling Log (Annexure-2)
- Status Change Log (Annexure-3)
- Rejected Material Disposal Log (Annexure-4)
- Warehouse Inspection Log (Annexure-5)
- 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 |