Standard Operating Procedure for Storage and Labeling of Expired and Obsolete Raw Materials
| Department | Warehouse / Quality Assurance / Regulatory Compliance |
|---|---|
| SOP No. | SOP/RM/163/2025 |
| Supersedes | SOP/RM/163/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 01/04/2025 |
| Effective Date | 08/04/2025 |
| Review Date | 01/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes guidelines for the identification, labeling, segregation, and storage of expired and obsolete raw materials to prevent accidental use and ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This SOP applies to all expired and obsolete raw materials stored in the warehouse, including active pharmaceutical ingredients (APIs), excipients, solvents, and packaging materials. It includes procedures for labeling, storage, documentation, and handling until proper disposal.
3. Responsibilities
- Warehouse Personnel: Identify, label, and segregate expired and obsolete materials. Ensure that records are accurately maintained.
- Warehouse Supervisor: Oversee the proper labeling and storage of expired materials and ensure that the segregation procedures are followed.
- Quality Assurance (QA): Verify the labeling and storage process, conduct periodic audits, and approve materials for disposal.
- Regulatory Compliance Officer: Ensure that procedures comply with applicable laws and guidelines for the handling of expired materials.
4. Accountability
The Warehouse Manager is accountable for ensuring the correct storage and labeling of expired and obsolete raw materials. The QA Manager is responsible for auditing compliance with this SOP and verifying that expired materials are handled properly.
5. Procedure
5.1 Identification and Labeling of Expired and Obsolete Materials
- Material Identification:
- Warehouse personnel must regularly review material expiry dates during monthly inventory checks.
- Materials that have passed their expiration date or are deemed obsolete due to regulatory changes or reformulations must be identified promptly.
- Document identified materials in the Expired Material Identification Log (Annexure-1).
- Labeling Requirements:
- Clearly label all expired or obsolete materials with a red “EXPIRED” or “OBSOLETE” sticker.
- Labels must include material name, batch number, expiry date, date of identification, and the name of the person labeling the material.
- Document labeling activities in the Labeling Log (Annexure-2).
5.2 Segregation and Storage of Expired and Obsolete Materials
- Segregation Guidelines:
- Store expired and obsolete materials in a dedicated quarantine area, physically separated from active inventory.
- Ensure materials are not accessible to production or quality control personnel without explicit authorization.
- Document the segregation in the Segregation Log (Annexure-3).
- Storage Conditions:
- Maintain proper storage conditions to prevent environmental hazards, particularly for hazardous materials.
- Ensure the quarantine area is clearly marked and access is limited to authorized personnel only.
- Record storage conditions in the Storage Condition Monitoring Log (Annexure-4).
5.3 Handling and Documentation of Expired Materials
- Documentation Requirements:
- Maintain complete documentation for all expired materials, including identification, labeling, segregation, and disposal records.
- Use the Expired Material Documentation Log (Annexure-5) for comprehensive record-keeping.
- Internal Audit and Verification:
- QA personnel must conduct monthly audits to verify that expired materials are correctly labeled, segregated, and documented.
- Document audit findings in the Audit Verification Log (Annexure-6).
5.4 Disposal of Expired and Obsolete Materials
- Approval for Disposal:
- Obtain written approval from the QA Manager and Regulatory Compliance Officer before disposing of any expired materials.
- Document disposal approvals in the Disposal Authorization Log (Annexure-7).
- Disposal Methods:
- Disposal must be conducted following environmental regulations and company policies. Hazardous materials should be disposed of through authorized waste disposal agencies.
- Document disposal activities in the Material Disposal Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Expired Material Identification Log (Annexure-1)
- Labeling Log (Annexure-2)
- Segregation Log (Annexure-3)
- Storage Condition Monitoring Log (Annexure-4)
- Expired Material Documentation Log (Annexure-5)
- Audit Verification Log (Annexure-6)
- Disposal Authorization Log (Annexure-7)
- Material Disposal Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- Environmental Protection Act for Waste Disposal Regulations
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Expired Material Identification Log
| Date | Material Name | Batch Number | Expiry Date | Identified By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | 31/03/2025 | Ravi Kumar |
| 01/04/2025 | Sodium Benzoate | SB-2023B | 28/02/2025 | Neha Verma |
Annexure-2: Labeling Log
| Date | Material Name | Batch Number | Label Applied | Labeled By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | EXPIRED | Amit Joshi |
| 01/04/2025 | Sodium Benzoate | SB-2023B | OBSOLETE | Priya Singh |
Annexure-3: Segregation Log
| Date | Material Name | Batch Number | Storage Area | Segregated By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | Quarantine Zone A | Ravi Kumar |
| 01/04/2025 | Sodium Benzoate | SB-2023B | Quarantine Zone B | Neha Verma |
Annexure-4: Storage Condition Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 01/04/2025 | Quarantine Zone A | 25°C | 45% | Amit Joshi |
| 01/04/2025 | Quarantine Zone B | 24°C | 50% | Priya Singh |
Annexure-5: Expired Material Documentation Log
| Date | Material Name | Batch Number | Documentation Complete (Yes/No) | Verified By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | Yes | Neha Verma |
| 01/04/2025 | Sodium Benzoate | SB-2023B | Yes | Ravi Kumar |
Annexure-6: Audit Verification Log
| Date | Auditor Name | Audit Findings | Corrective Actions Required | Verified By |
|---|---|---|---|---|
| 01/04/2025 | QA Manager | No discrepancies found | None | QA Head |
Annexure-7: Disposal Authorization Log
| Date | Material Name | Batch Number | Quantity Approved for Disposal | Authorized By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | 50 kg | QA Manager |
| 01/04/2025 | Sodium Benzoate | SB-2023B | 30 kg | Regulatory Compliance Officer |
Annexure-8: Material Disposal Log
| Date | Material Name | Batch Number | Quantity Disposed | Disposal Method | Disposed By |
|---|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2023A | 50 kg | Incineration | Authorized Disposal Agency |
| 01/04/2025 | Sodium Benzoate | SB-2023B | 30 kg | Chemical Neutralization | Authorized Disposal Agency |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 01/04/2025 | 2.0 | Added Detailed Disposal Documentation | Regulatory Compliance Update | QA Head |