Standard Operating Procedure for Handling and Storing Raw Materials with Short Shelf Life
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/121/2025 |
| Supersedes | SOP/RM/121/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 20/02/2025 |
| Effective Date | 24/02/2025 |
| Review Date | 20/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for the proper handling and storage of raw materials with short shelf life to ensure their quality and prevent expiration before use.
2. Scope
This SOP applies to all raw materials with a shelf life of 12 months or less, stored in the warehouse, including APIs, excipients, and reagents.
3. Responsibilities
- Warehouse Personnel: Ensure proper handling, storage, and monitoring of short-shelf-life materials.
- Warehouse Manager: Oversee storage procedures and ensure compliance with this SOP.
- Quality Assurance (QA): Verify material status and conduct periodic audits to ensure compliance with GMP.
4. Accountability
The Warehouse Manager is accountable for the implementation of this SOP, while the QA Manager ensures regulatory compliance and quality standards are met.
5. Procedure
5.1 Identification and Labeling
- Material Identification:
- Clearly identify raw materials with a shelf life of 12 months or less during
receipt and inspection.
Use bright-colored labels (e.g., red or orange) to mark short-shelf-life materials for easy identification.
Record material details in the Short Shelf Life Material Register (Annexure-1).
Labeling Requirements:
- Labels must include material name, batch number, manufacturing date, expiry date, and storage conditions.
- Include a “USE FIRST” indicator on labels to prioritize usage.
- Document labeling in the Label Verification Log (Annexure-2).
5.2 Storage Conditions
- Temperature Control:
- Store temperature-sensitive materials in designated cold storage or controlled environments as per the manufacturer’s guidelines.
- Monitor and document temperature readings twice daily in the Temperature Monitoring Log (Annexure-3).
- Humidity Control:
- Store hygroscopic materials in moisture-controlled environments using desiccants or humidity chambers.
- Monitor humidity levels daily and document in the Humidity Monitoring Log (Annexure-4).
- Storage Arrangement:
- Place short-shelf-life materials in easily accessible locations for quick retrieval.
- Follow First-Expiry, First-Out (FEFO) principles to ensure timely usage.
- Document storage location details in the Storage Location Log (Annexure-5).
5.3 Handling Procedures
- Material Handling:
- Handle materials with care to prevent contamination, degradation, or accidental exposure.
- Use appropriate Personal Protective Equipment (PPE) based on the material’s safety data sheet (SDS).
- Document handling activities in the Handling Log (Annexure-6).
- Material Issuance:
- Before issuing materials for production, verify that the material is within its expiry period.
- Document issuance in the Material Issuance Log (Annexure-7).
5.4 Monitoring and Review
- Daily Monitoring:
- Warehouse personnel must check the condition of short-shelf-life materials daily for signs of degradation.
- Document observations in the Daily Monitoring Log (Annexure-8).
- QA Review:
- QA will conduct monthly reviews of short-shelf-life materials to ensure compliance with GMP.
- Document QA reviews in the QA Review Log (Annexure-9).
5.5 Handling Expired Materials
- Identification of Expired Materials:
- Immediately identify and segregate expired materials from usable stock.
- Label expired materials as “EXPIRED – DO NOT USE” and store in the designated rejection area.
- Document expired materials in the Expired Material Log (Annexure-10).
- Disposal of Expired Materials:
- Dispose of expired materials following company protocols and regulatory guidelines.
- Document disposal activities in the Disposal Log (Annexure-11).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- FEFO: First-Expiry, First-Out
- SDS: Safety Data Sheet
7. Documents
- Short Shelf Life Material Register (Annexure-1)
- Label Verification Log (Annexure-2)
- Temperature Monitoring Log (Annexure-3)
- Humidity Monitoring Log (Annexure-4)
- Storage Location Log (Annexure-5)
- Handling Log (Annexure-6)
- Material Issuance Log (Annexure-7)
- Daily Monitoring Log (Annexure-8)
- QA Review Log (Annexure-9)
- Expired Material Log (Annexure-10)
- Disposal Log (Annexure-11)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Hazardous Material Handling Standards
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Short Shelf Life Material Register
| Date | Material Name | Batch Number | Expiry Date | Storage Condition |
|---|---|---|---|---|
| 20/02/2025 | API A | Batch 001 | 20/05/2025 | 2-8°C |
Annexure-2: Label Verification Log
| Date | Material Name | Label Verified By | Remarks |
|---|---|---|---|
| 20/02/2025 | API A | Ravi Kumar | Label Verified and Correct |
Annexure-3: Temperature Monitoring Log
| Date | Time | Temperature (°C) | Recorded By |
|---|---|---|---|
| 20/02/2025 | 08:00 AM | 4°C | Sunita Sharma |
Annexure-4: Humidity Monitoring Log
| Date | Time | Humidity (%) | Recorded By |
|---|---|---|---|
| 20/02/2025 | 08:00 AM | 45% | Anjali Mehta |
Annexure-5: Storage Location Log
| Date | Material Name | Storage Area | Placed By |
|---|---|---|---|
| 20/02/2025 | API A | Cold Storage Unit 1 | Ravi Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 20/02/2025 | 2.0 | Updated Handling and Storage Procedures | Regulatory Compliance | QA Head |