Standard Operating Procedure for Storage of Raw Materials for Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/003/2025 |
| Supersedes | SOP/ELX/003/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 12/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 12/04/2026 |
1. Purpose
To define the procedure for proper storage of raw materials including APIs, excipients, and solvents used in elixir manufacturing to maintain their quality, identity, strength, and purity throughout the storage duration.
2. Scope
This SOP is applicable to all raw materials received and intended for use in the Elixir Department, stored in designated warehouses under specified conditions until issuance for manufacturing.
3. Responsibilities
- Warehouse Staff:
- Ensure proper storage conditions and segregation.
- Monitor temperature and humidity.
- Maintain storage records and inventory.
- Quality Assurance (QA):
- Ensure compliance with storage SOP and approve material movement between areas.
4. Accountability
The Head of Warehouse and Head of QA are jointly accountable for adherence to this SOP and for the quality of stored materials.
5. Procedure
5.1 Warehouse Zoning
- Divide the warehouse into the
following designated zones:
Clearly mark zones and maintain physical barriers as applicable.
- Quarantine Area
- Approved Material Storage
- Rejected Material Area
- Under Test Area
- Controlled Substance Area (if applicable)
5.2 Material Segregation
- Store materials by category:
- APIs separately from excipients and solvents
- Hazardous materials in accordance with MSDS guidelines
- Light-sensitive or humidity-sensitive materials in appropriate containers
5.3 Environmental Conditions
- Monitor and record temperature and humidity twice daily using calibrated hygrometers and thermometers.
- Standard storage conditions:
- Ambient: 15°C to 25°C
- Refrigerated: 2°C to 8°C (if applicable)
- Humidity: Not more than 60% RH
- Take corrective action if deviations occur and notify QA.
5.4 Material Storage Practice
- Place materials on clean, labeled pallets—never directly on the floor.
- Ensure labels face outward and are easily visible.
- Use FIFO (First In, First Out) or FEFO (First Expiry, First Out) system as appropriate.
- Affix status labels:
- “Under Test” – Before QC release
- “Approved” – After QC approval
- “Rejected” – After QC rejection
5.5 Storage of Volatile and Flammable Materials
- Store in flameproof cabinets or designated flameproof areas with ventilation.
- Ensure fire extinguishers are available and inspected monthly.
5.6 Pest Control and Housekeeping
- Conduct pest control activities monthly through authorized agencies.
- Clean the warehouse floors, shelves, and surroundings daily using dry or damp mopping.
- Spillages should be cleaned immediately and reported in the cleaning logbook.
5.7 Record Keeping
- Maintain the following logs:
- Material Location Log (Annexure-1)
- Temperature and Humidity Log (Annexure-2)
- Pest Control Log (Annexure-3)
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- MSDS: Material Safety Data Sheet
- FIFO: First In, First Out
- FEFO: First Expiry, First Out
7. Documents
- Material Location Log (Annexure-1)
- Temperature and Humidity Log (Annexure-2)
- Pest Control Log (Annexure-3)
8. References
- WHO GMP Guide – Storage of Pharmaceutical Products
- 21 CFR Part 211.80 – Storage and Distribution
- ICH Q7 – Good Manufacturing Practice for APIs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Location Log
| Material Name | Batch No. | Zone | Location Code | Status | Date Stored |
|---|---|---|---|---|---|
| Sodium Benzoate | SB/0425/008 | Approved Area | R-12-A | Approved | 12/04/2025 |
Annexure-2: Temperature and Humidity Log
| Date | Time | Temperature (°C) | Humidity (% RH) | Checked By | Remarks |
|---|---|---|---|---|---|
| 12/04/2025 | 09:00 | 23.1 | 52 | Rajesh Kumar | Within Limit |
Annexure-3: Pest Control Log
| Date | Agency | Service Type | Service Done By | Remarks |
|---|---|---|---|---|
| 10/04/2025 | CleanTech Services | Rodent & Insect Control | Sunil Patil | Completed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 12/04/2025 | 2.0 | Updated zoning and monitoring controls | Compliance and clarity | QA Head |