Standard Operating Procedure for Managing Storage of Dry and Liquid Raw Materials Separately
| Department | Warehouse / Quality Assurance / Safety |
|---|---|
| SOP No. | SOP/RM/158/2025 |
| Supersedes | SOP/RM/158/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 27/03/2025 |
| Effective Date | 03/04/2025 |
| Review Date | 27/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes guidelines for the proper segregation and storage of dry and liquid raw materials to prevent cross-contamination, ensure safety, and maintain material integrity. This procedure aligns with Good Manufacturing Practices (GMP) and safety standards for raw material handling.
2. Scope
This SOP applies to all personnel involved in the handling and storage of dry and liquid raw materials in the warehouse. It includes procedures for the identification, labeling, segregation, and monitoring of these materials to ensure compliance with GMP.
3. Responsibilities
- Warehouse Personnel: Ensure correct storage of dry and liquid materials as per this SOP. Report any deviations or storage issues immediately.
- Warehouse Supervisor: Oversee storage operations, verify segregation procedures, and ensure proper labeling.
- Quality Assurance (QA): Conduct regular audits to ensure compliance with storage requirements and verify documentation.
- Safety Officer: Ensure storage areas meet safety standards, especially for flammable or hazardous liquids.
4. Accountability
The Warehouse Manager is accountable for ensuring the proper segregation and storage of dry and liquid raw materials. The QA Manager is responsible for regular audits and ensuring compliance with this SOP.
5. Procedure
5.1 Identification and Labeling of Dry and Liquid Raw Materials
- Material Classification:
- Classify raw materials as either Dry (e.g., powders, granules) or Liquid (e.g., solvents, oils).
- Hazardous materials must be identified based on their chemical properties and MSDS (Material Safety Data Sheet).
- Document classifications in the Material Classification Log (Annexure-1).
- Labeling Requirements:
- Clearly label all materials with their classification, batch number, storage requirements, and hazard symbols if applicable.
- Use color-coded labels to distinguish dry (e.g., blue) from liquid (e.g., red) materials.
- Document labeling status in the Material Labeling Log (Annexure-2).
5.2 Segregation and Storage Procedures
- Dedicated Storage Areas:
- Store dry materials in dedicated, moisture-free storage areas to prevent humidity exposure.
- Store liquid materials in separate, well-ventilated storage areas with spill containment measures.
- Flammable liquids must be stored in fireproof cabinets with appropriate ventilation.
- Document storage locations in the Material Storage Log (Annexure-3).
- Stacking and Shelving:
- Ensure dry materials are stored on pallets or shelves to avoid direct contact with the floor.
- Store liquid materials in leak-proof containers on secondary containment trays.
- Document stacking and shelving arrangements in the Storage Arrangement Log (Annexure-4).
5.3 Handling and Safety Measures
- Personal Protective Equipment (PPE):
- Warehouse personnel must wear appropriate PPE, including gloves, goggles, and masks when handling hazardous liquids.
- Document PPE compliance in the PPE Compliance Log (Annexure-5).
- Spill Response Procedures:
- In case of liquid spills, immediately contain the spill using absorbent materials and notify the Warehouse Supervisor.
- Ensure that spill kits are readily available in all liquid storage areas.
- Document spill incidents in the Spill Incident Log (Annexure-6).
5.4 Monitoring and Inspections
- Routine Inspections:
- Conduct weekly inspections to ensure proper segregation of dry and liquid materials and verify storage conditions.
- Inspect containers for signs of leakage, damage, or contamination.
- Document inspection results in the Storage Inspection Log (Annexure-7).
- Corrective Actions:
- Immediately correct any deviations from the segregation protocol.
- Document corrective actions in the Corrective Action Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- MSDS: Material Safety Data Sheet
7. Documents
- Material Classification Log (Annexure-1)
- Material Labeling Log (Annexure-2)
- Material Storage Log (Annexure-3)
- Storage Arrangement Log (Annexure-4)
- PPE Compliance Log (Annexure-5)
- Spill Incident Log (Annexure-6)
- Storage Inspection Log (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
- OSHA Guidelines for Safe Handling of Chemicals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Material Classification Log
| Date | Material Name | Batch Number | Classification (Dry/Liquid) | Classified By |
|---|---|---|---|---|
| 27/03/2025 | Sodium Chloride | SC-1234 | Dry | Ravi Kumar |
| 27/03/2025 | Isopropyl Alcohol | IPA-5678 | Liquid | Neha Verma |
Annexure-2: Material Labeling Log
| Date | Material Name | Batch Number | Label Applied | Labeled By |
|---|---|---|---|---|
| 27/03/2025 | Sodium Chloride | SC-1234 | Dry (Blue Label) | Amit Joshi |
| 27/03/2025 | Isopropyl Alcohol | IPA-5678 | Liquid (Red Label) | Priya Singh |
Annexure-3: Material Storage Log
| Date | Material Name | Storage Area | Storage Conditions | Stored By |
|---|---|---|---|---|
| 27/03/2025 | Sodium Chloride | Dry Storage Room A | Humidity-Controlled, Sealed | Ravi Kumar |
| 27/03/2025 | Isopropyl Alcohol | Liquid Storage Room B | Ventilated, Flammable Cabinet | Neha Verma |
Annexure-4: Storage Arrangement Log
| Date | Storage Area | Arrangement Type | Verified By |
|---|---|---|---|
| 27/03/2025 | Dry Storage Room A | Stacked on Pallets | Amit Joshi |
| 27/03/2025 | Liquid Storage Room B | Secondary Containment Trays | Priya Singh |
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 |
| 27/03/2025 | 2.0 | Added Spill Response and Monitoring Procedures | Improve Material Safety and Compliance | QA Head |