Standard Operating Procedure for Proper Use of Storage Bin Systems for Raw Materials
| Department | Warehouse / Quality Assurance / Inventory Management |
|---|---|
| SOP No. | SOP/RM/185/2025 |
| Supersedes | SOP/RM/185/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 20/04/2025 |
| Effective Date | 27/04/2025 |
| Review Date | 20/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the correct method for using storage bin systems for organizing, storing, and managing raw materials to ensure compliance with Good Manufacturing Practices (GMP) and efficient warehouse operations.
2. Scope
This SOP applies to all warehouse personnel involved in the storage, handling, and organization of raw materials using bin systems. It includes procedures for labeling, tracking, and maintaining bin systems.
3. Responsibilities
- Warehouse Personnel: Ensure proper placement, labeling, and tracking of raw materials in bin systems.
- Quality Assurance (QA) Team: Verify that the storage system complies with GMP standards and conduct regular audits.
- Inventory Management Team: Monitor bin utilization and ensure accurate recording of material movements.
4. Accountability
The Warehouse Manager is accountable for the correct use of bin systems, the QA Manager ensures compliance with GMP requirements, and the Inventory Manager oversees the accuracy of bin assignments and stock
levels.
5. Procedure
5.1 Bin System Setup and Maintenance
- Bin Identification:
- Assign unique identification codes to each bin, ensuring clear labeling and easy identification.
- Document bin identification details in the Bin Identification Log (Annexure-1).
- Bin Maintenance:
- Conduct regular cleaning and inspection of bins to prevent contamination and ensure integrity.
- Record maintenance activities in the Bin Maintenance Log (Annexure-2).
5.2 Material Placement and Tracking
- Material Placement:
- Store raw materials in designated bins according to material classification, ensuring segregation of incompatible materials.
- Record material placement in the Material Placement Log (Annexure-3).
- Material Movement Tracking:
- Track all movements of materials in and out of bins, ensuring accurate inventory control.
- Document movements in the Material Movement Log (Annexure-4).
5.3 Labeling and Documentation
- Labeling Requirements:
- Ensure each bin is labeled with material name, batch number, expiry date, and storage conditions.
- Document labeling details in the Bin Labeling Log (Annexure-5).
- Documentation Integrity:
- Ensure that all entries into the bin management system are accurate and comply with data integrity requirements.
- Record documentation checks in the Documentation Integrity Log (Annexure-6).
5.4 Safety and Compliance Measures
- Segregation of Hazardous Materials:
- Ensure hazardous materials are stored in designated bins, separate from non-hazardous materials.
- Document segregation compliance in the Hazardous Material Segregation Log (Annexure-7).
- Regular Audits:
- Conduct periodic audits to verify compliance with bin storage procedures and GMP standards.
- Record audit findings in the Bin Storage Audit Log (Annexure-8).
5.5 Training and Continuous Improvement
- Personnel Training:
- Conduct regular training for warehouse staff on proper bin usage and material handling procedures.
- Document training sessions in the Training Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Bin Identification Log (Annexure-1)
- Bin Maintenance Log (Annexure-2)
- Material Placement Log (Annexure-3)
- Material Movement Log (Annexure-4)
- Bin Labeling Log (Annexure-5)
- Documentation Integrity Log (Annexure-6)
- Hazardous Material Segregation Log (Annexure-7)
- Bin Storage Audit Log (Annexure-8)
- Training Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Good Storage Practices for Pharmaceuticals
- OSHA Guidelines on Warehouse Safety
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Bin Identification Log
| Date | Bin ID | Location | Assigned By |
|---|---|---|---|
| 20/04/2025 | BIN-001 | Zone A | Ravi Kumar |
Annexure-2: Bin Maintenance Log
| Date | Bin ID | Maintenance Activity | Performed By |
|---|---|---|---|
| 20/04/2025 | BIN-001 | Cleaned and inspected | Neha Verma |
Annexure-3: Material Placement Log
| Date | Material Name | Bin ID | Placed By |
|---|---|---|---|
| 20/04/2025 | API X | BIN-001 | Amit Joshi |
Annexure-4: Material Movement Log
| Date | Material Name | From Bin | To Bin | Moved By |
|---|---|---|---|---|
| 20/04/2025 | API Y | BIN-002 | BIN-003 | Kiran Patel |
Annexure-5: Bin Labeling Log
| Date | Bin ID | Label Type | Labeled By |
|---|---|---|---|
| 20/04/2025 | BIN-001 | Red (Hazardous) | QA Supervisor |
Annexure-6: Documentation Integrity Log
| Date | Document Name | Checked By | Status |
|---|---|---|---|
| 20/04/2025 | Material Movement Log | Sanjay Mehta | Verified |
Annexure-7: Hazardous Material Segregation Log
| Date | Material Name | Bin ID | Verified By |
|---|---|---|---|
| 20/04/2025 | Solvent Z | BIN-005 | QA Manager |
Annexure-8: Bin Storage Audit Log
| Date | Audit Area | Findings | Audited By |
|---|---|---|---|
| 20/04/2025 | Bin Storage System | No discrepancies found | QA Head |
Annexure-9: Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 20/04/2025 | Ravi Kumar | Proper Use of Bin Systems | QA Manager | Completed Successfully |
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 |
| 20/04/2025 | 2.0 | Updated procedures for bin management and documentation. | Regulatory Update | QA Head |