Procedure for Raw Material Storage in Designated Areas
| Department | Warehouse/Quality Control |
|---|---|
| SOP No. | SOP/Ointment/002 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
This Standard Operating Procedure (SOP) outlines the proper storage of raw materials used in ointment manufacturing. The objective is to ensure materials are stored in compliance with Good Manufacturing Practices (GMP) to maintain their integrity, prevent contamination, and facilitate traceability.
2. Scope
This SOP applies to all raw materials stored in the designated warehouse areas before their use in production. It includes guidelines for material handling, environmental conditions, labeling, segregation, and inventory management.
3. Responsibilities
- Warehouse Personnel: Ensure proper storage and labeling of raw materials.
- Quality Control (QC) Personnel: Verify compliance with storage conditions.
- Production Supervisor: Monitor stock levels and ensure proper utilization.
- Quality Assurance (QA) Officer: Conduct periodic audits of storage areas.
4. Accountability
The Warehouse Manager is accountable for ensuring all raw materials are stored according to GMP guidelines and company standards.
5. Procedure
5.1 Storage Area Requirements
- Maintain a clean, organized, and temperature-controlled storage area.
- Ensure proper ventilation and protection from direct sunlight, moisture, and contaminants.
- Designate separate areas for quarantine, approved, and rejected materials.
- Use temperature and humidity monitoring systems to maintain required environmental conditions.
5.2 Storage Conditions
- Store
materials at specified temperature and humidity levels as per manufacturer recommendations.
Ensure that highly sensitive materials are stored under refrigerated or controlled conditions.
Keep volatile and hazardous materials in designated safety cabinets.
Maintain segregation between raw materials, intermediates, and finished products.
5.3 Handling and Placement
- Use designated forklifts and trolleys for material movement.
- Follow First-In, First-Out (FIFO) and First-Expired, First-Out (FEFO) principles.
- Ensure materials are stored on pallets or racks, not directly on the floor.
- Stack materials as per weight-bearing capacity and stability guidelines.
5.4 Labeling and Identification
- Each container must have a clear label with material name, batch number, expiry date, and status (Quarantine/Approved/Rejected).
- Ensure color-coded labeling for easy identification:
- Green Label – Approved
- Red Label – Rejected
- Yellow Label – Quarantine
- Maintain a digital record of material locations using inventory management software.
5.5 Quarantine and Rejected Material Handling
- Place all newly received raw materials in the quarantine area until QC approval.
- Ensure rejected materials are segregated and marked for return or disposal.
- Dispose of expired or damaged materials as per hazardous waste management guidelines.
5.6 Inventory Management
- Perform regular stock verification to maintain accurate inventory records.
- Update stock movements in the ERP (Enterprise Resource Planning) system.
- Conduct monthly audits to reconcile physical and recorded inventory.
5.7 Periodic Cleaning and Maintenance
- Schedule routine cleaning of storage racks, pallets, and floors.
- Monitor pest control measures and maintain logs.
- Ensure proper maintenance of air conditioning and dehumidification systems.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- FIFO – First-In, First-Out
- FEFO – First-Expired, First-Out
7. Documents
- Raw Material Storage Log (Annexure-1)
- Temperature and Humidity Monitoring Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Storage
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Guidelines for Storage of Raw Materials
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Raw Material Storage Log
| Date | Material Name | Batch Number | Storage Location | Temperature (°C) | Humidity (%) |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | Rack A1 | 22 | 45 |
| 02/02/2025 | Material B | Batch 67890 | Rack B2 | 25 | 50 |
Annexure-2: Temperature and Humidity Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Checked By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | Cold Storage | 5 | 40 | John Doe | Within range |
| 02/02/2025 | Main Warehouse | 22 | 45 | Jane Smith | Within range |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head | All | All | Created new SOP |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head | All | All | Revised to meet new documentation standards |