Standard Operating Procedure for Handling and Storing Raw Materials in Open Shelving Systems
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/164/2025 |
| Supersedes | SOP/RM/164/2022 |
| 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) provides guidelines for the proper handling and storage of raw materials in open shelving systems. It ensures materials are protected from contamination, cross-contamination, and environmental degradation while maintaining compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials stored on open shelving systems within the warehouse, including active pharmaceutical ingredients (APIs), excipients, and packaging materials.
3. Responsibilities
- Warehouse Personnel: Handle and store raw materials following this SOP. Ensure shelves are clean, organized, and materials are properly labeled.
- Warehouse Supervisor: Oversee storage practices, verify compliance, and ensure environmental conditions are maintained.
- Quality Assurance (QA): Conduct audits of storage conditions and ensure compliance with GMP requirements.
4. Accountability
The Warehouse Manager is accountable for the correct implementation of this SOP. The QA Manager is responsible for verifying compliance through routine inspections and audits.
5. Procedure
5.1 Preparation of Open Shelving Systems
- Shelving Requirements:
- Use non-reactive, rust-proof, and easy-to-clean shelving materials such as stainless steel or coated metal.
- Ensure shelves are stable, securely fastened, and capable of supporting the weight of stored materials.
- Maintain a minimum distance of 6 inches from the floor to prevent moisture contamination.
- Document shelving inspections in the Shelving Inspection Log (Annexure-1).
- Cleaning and Sanitization:
- Clean and sanitize shelves before placing any raw materials, and perform regular cleaning based on a pre-defined schedule.
- Document cleaning activities in the Shelving Cleaning Log (Annexure-2).
5.2 Material Handling Procedures
- Receiving and Verification:
- Upon receipt, verify that raw materials are free from damage and meet quality standards before storage.
- Ensure materials are labeled correctly with batch number, material name, and expiration date.
- Document material verification in the Material Receiving Log (Annexure-3).
- Placement on Shelves:
- Arrange materials on shelves by type, batch number, and expiry date to facilitate FIFO (First In, First Out) or FEFO (First Expired, First Out) practices.
- Ensure materials are not stacked beyond safe limits to avoid toppling.
- Maintain at least 12 inches of space between materials and walls to promote air circulation.
- Record shelf placement in the Material Placement Log (Annexure-4).
5.3 Environmental Monitoring and Maintenance
- Environmental Control:
- Monitor temperature and humidity levels daily to ensure they remain within acceptable ranges for each material.
- Install thermometers and hygrometers at strategic locations within the storage area.
- Document environmental conditions in the Environmental Monitoring Log (Annexure-5).
- Routine Inspections:
- Conduct weekly inspections to identify signs of contamination, spillage, or pest infestation.
- Document inspection findings in the Storage Area Inspection Log (Annexure-6).
5.4 Handling Non-Conformities and Damaged Materials
- Identification of Issues:
- If materials are found damaged, contaminated, or expired, they must be labeled as “Quarantined” and moved to a designated area.
- Record non-conformities in the Non-Conformity Report (Annexure-7).
- Corrective Actions:
- Investigate the cause of non-conformities and implement corrective actions.
- Document corrective actions in the Corrective Action Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- FIFO: First In, First Out
- FEFO: First Expired, First Out
7. Documents
- Shelving Inspection Log (Annexure-1)
- Shelving Cleaning Log (Annexure-2)
- Material Receiving Log (Annexure-3)
- Material Placement Log (Annexure-4)
- Environmental Monitoring Log (Annexure-5)
- Storage Area Inspection Log (Annexure-6)
- Non-Conformity Report (Annexure-7)
- Corrective Action 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
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Shelving Inspection Log
| Date | Shelf Location | Inspection Findings | Inspected By |
|---|---|---|---|
| 01/04/2025 | Aisle 1, Shelf A | No damage, secure installation | Ravi Kumar |
| 01/04/2025 | Aisle 2, Shelf B | Minor rust on lower frame | Neha Verma |
Annexure-2: Shelving Cleaning Log
| Date | Shelf Location | Cleaning Method | Cleaned By |
|---|---|---|---|
| 01/04/2025 | Aisle 1, Shelf A | Sanitized with 70% IPA | Amit Joshi |
| 01/04/2025 | Aisle 2, Shelf B | Sanitized with disinfectant spray | Priya Singh |
Annexure-3: Material Receiving Log
| Date | Material Name | Batch Number | Condition on Receipt | Received By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2025A | Good | Ravi Kumar |
| 01/04/2025 | Sodium Benzoate | SB-2025B | No damage | Neha Verma |
Annexure-4: Material Placement Log
| Date | Material Name | Batch Number | Shelf Location | Placed By |
|---|---|---|---|---|
| 01/04/2025 | Paracetamol API | PA-2025A | Aisle 1, Shelf A | Amit Joshi |
| 01/04/2025 | Sodium Benzoate | SB-2025B | Aisle 2, Shelf B | Priya Singh |
Annexure-5: Environmental Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 01/04/2025 | Aisle 1 | 24°C | 45% | Amit Joshi |
| 01/04/2025 | Aisle 2 | 23°C | 50% | Priya Singh |
Annexure-6: Storage Area Inspection Log
| Date | Storage Area | Inspection Findings | Inspected By |
|---|---|---|---|
| 01/04/2025 | Aisle 1 | No issues | Ravi Kumar |
| 01/04/2025 | Aisle 2 | Pest droppings found | Neha Verma |
Annexure-7: Non-Conformity Report
| Date | Material Name | Batch Number | Non-Conformity Description | Reported By |
|---|---|---|---|---|
| 01/04/2025 | Sodium Benzoate | SB-2025B | Pest contamination | Neha Verma |
Annexure-8: Corrective Action Log
| Date | Non-Conformity | Corrective Action Taken | Verified By |
|---|---|---|---|
| 01/04/2025 | Pest contamination in Aisle 2 | Material quarantined, pest control performed | Amit Joshi |
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 Non-Conformity and Corrective Action Procedures | Enhance Storage Compliance | QA Head |