Standard Operating Procedure for Handling and Storing Raw Materials in Large Drums and Carboys
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/129/2025 |
| Supersedes | SOP/RM/129/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 26/02/2025 |
| Effective Date | 01/03/2025 |
| Review Date | 26/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the guidelines for safely handling and storing raw materials in large drums and carboys to ensure material integrity, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials stored in large drums and carboys, including solvents, chemicals, and other bulk materials received and stored in the warehouse.
3. Responsibilities
- Warehouse Personnel: Responsible for the proper handling, inspection, and storage of raw materials in large drums and carboys.
- Warehouse Manager: Oversee receiving, handling, and storage operations to ensure adherence to this SOP.
- Quality Assurance (QA): Inspect storage practices, verify compliance with specifications, and approve storage conditions.
4. Accountability
The Warehouse Manager is accountable for implementing safe handling and storage procedures, while the QA Manager ensures compliance with regulatory and quality standards.
5. Procedure
5.1 Receiving and
Inspection
- Inspection at Receipt:
- Inspect large drums and carboys upon arrival for visible damage, leaks, or signs of contamination.
- Ensure packaging integrity, such as intact seals and secure closures.
- Verify materials against the purchase order and accompanying documentation (e.g., Certificate of Analysis, MSDS).
- Document findings in the Receiving Inspection Log (Annexure-1).
- Verification of Documentation:
- Check batch numbers, expiry dates, and specifications on the delivery documentation.
- Ensure all materials have the appropriate regulatory certificates and safety data sheets.
- Record documentation verification in the Document Compliance Log (Annexure-2).
5.2 Handling of Large Drums and Carboys
- Use of Handling Equipment:
- Use forklifts, drum trolleys, or pallet jacks designed for handling heavy loads to transport drums and carboys.
- Ensure equipment is regularly inspected and maintained for safe operation.
- Document equipment usage in the Handling Equipment Log (Annexure-3).
- Manual Handling Procedures:
- If manual handling is necessary, ensure that two or more trained personnel are involved.
- Use proper lifting techniques to prevent injury or material spillage.
- Record manual handling activities in the Manual Handling Log (Annexure-4).
5.3 Storage of Large Drums and Carboys
- Storage Conditions:
- Store drums and carboys upright on pallets to prevent direct contact with the floor and ensure stability.
- Secure drums and carboys with straps or barriers to prevent movement during storage.
- Document storage conditions in the Storage Log (Annexure-5).
- Segregation and Labeling:
- Segregate materials based on their nature (flammable, corrosive, etc.) and store in designated areas with appropriate signage.
- Ensure all containers are labeled with material name, batch number, expiry date, and hazard information.
- Record segregation and labeling compliance in the Segregation and Labeling Log (Annexure-6).
5.4 Environmental Controls
- Temperature and Humidity Control:
- Monitor storage conditions to ensure materials are kept within specified temperature and humidity ranges.
- Document environmental conditions in the Temperature and Humidity Log (Annexure-7).
- Airflow and Ventilation:
- Ensure proper airflow in storage areas to prevent the accumulation of vapors and maintain material integrity.
- Conduct regular inspections of ventilation systems and document in the Environmental Control Log (Annexure-8).
5.5 Handling Deviations and Corrective Actions
- Reporting Deviations:
- Immediately report any deviations, such as damaged containers, improper storage, or unsafe handling, to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-9).
- Corrective Actions:
- Investigate the cause of deviations and implement corrective actions such as re-labeling, relocating materials, or retraining staff.
- Document corrective actions in the Corrective Action Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- COA: Certificate of Analysis
- MSDS: Material Safety Data Sheet
7. Documents
- Receiving Inspection Log (Annexure-1)
- Document Compliance Log (Annexure-2)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Standards for Safe Material Handling
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Receiving Inspection Log
| Date | Material Name | Container Type | Condition at Receipt | Inspected By |
|---|---|---|---|---|
| 26/02/2025 | Solvent X | Drum | No Damage | Ravi Kumar |
Annexure-2: Document Compliance Log
| Date | Material Name | Document Type | Status | Verified By |
|---|---|---|---|---|
| 26/02/2025 | Solvent X | COA | Verified | Sunita Sharma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 26/02/2025 | 2.0 | Updated Handling and Storage Procedures | Regulatory Compliance | QA Head |