Standard Operating Procedure for Verification of Storage Conditions During Warehouse Inspections
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/174/2025 |
| Supersedes | SOP/RM/174/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 09/04/2025 |
| Effective Date | 16/04/2025 |
| Review Date | 09/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for verifying storage conditions during warehouse inspections to ensure raw materials are stored in compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This SOP applies to all personnel involved in warehouse management and quality assurance responsible for inspecting, monitoring, and verifying storage conditions of raw materials within the warehouse.
3. Responsibilities
- Warehouse Personnel: Ensure storage conditions meet specified requirements and assist during inspections.
- Quality Assurance (QA) Team: Conduct regular inspections, verify compliance, and document findings.
- Warehouse Manager: Oversee corrective actions for any deviations identified during inspections.
4. Accountability
The QA Manager is accountable for ensuring that inspections are performed as per the SOP and that storage conditions comply with regulatory standards. The Warehouse Manager is responsible for implementing corrective actions.
5. Procedure
5.1 Pre-Inspection Preparation
- Inspection Schedule:
- Create and maintain a Warehouse Inspection Schedule (Annexure-1) to ensure
regular inspections.
Notify warehouse personnel at least 24 hours in advance of scheduled inspections.
Inspection Checklist Preparation:
- Prepare a Storage Condition Verification Checklist (Annexure-2) for each inspection.
5.2 Conducting the Inspection
- Environmental Condition Monitoring:
- Verify temperature and humidity using calibrated equipment. Document findings in the Environmental Condition Log (Annexure-3).
- Check for proper airflow, ventilation, and absence of moisture.
- Storage Compliance Verification:
- Confirm that materials are stored according to labeling instructions (e.g., temperature-sensitive, light-sensitive).
- Document compliance in the Storage Compliance Log (Annexure-4).
- Inspection of Hazardous and Sensitive Materials:
- Inspect storage conditions for hazardous, flammable, and sensitive materials. Document findings in the Hazardous Material Storage Log (Annexure-5).
5.3 Post-Inspection Activities
- Documentation of Findings:
- Complete the Warehouse Inspection Report (Annexure-6) summarizing findings, non-conformances, and corrective actions required.
- Non-Conformance and Corrective Actions:
- Record non-conformances in the Non-Conformance Report (Annexure-7) and assign corrective actions.
- Follow up on corrective actions and document completion in the Corrective Action Log (Annexure-8).
- Training and Continuous Improvement:
- Conduct training sessions based on inspection findings and document attendance in the Inspection-Based Training Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- NC: Non-Conformance
7. Documents
- Warehouse Inspection Schedule (Annexure-1)
- Storage Condition Verification Checklist (Annexure-2)
- Environmental Condition Log (Annexure-3)
- Storage Compliance Log (Annexure-4)
- Hazardous Material Storage Log (Annexure-5)
- Warehouse Inspection Report (Annexure-6)
- Non-Conformance Report (Annexure-7)
- Corrective Action Log (Annexure-8)
- Inspection-Based Training Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Storage Practices for Pharmaceuticals
- FDA Guidance on Warehouse Inspections
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Warehouse Inspection Schedule
| Inspection Date | Area to be Inspected | Inspector Name | Remarks |
|---|---|---|---|
| 09/04/2025 | Temperature-Controlled Storage | Ravi Kumar | Scheduled |
Annexure-2: Storage Condition Verification Checklist
| Checklist Item | Status (Compliant/Non-Compliant) | Remarks |
|---|---|---|
| Temperature within range | Compliant | Maintained at 25°C |
| Humidity within range | Non-Compliant | Above 65% |
Annexure-3: Environmental Condition Log
| Date | Area | Temperature (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 09/04/2025 | Cold Storage | 4°C | 50% | Neha Verma |
Annexure-4: Storage Compliance Log
| Date | Material Name | Storage Condition | Compliance Status | Inspected By |
|---|---|---|---|---|
| 09/04/2025 | API X | 25°C, 60% RH | Compliant | Amit Joshi |
Annexure-5: Hazardous Material Storage Log
| Date | Material Name | Hazard Type | Storage Compliance | Inspected By |
|---|---|---|---|---|
| 09/04/2025 | Solvent Y | Flammable | Compliant | Priya Singh |
Annexure-6: Warehouse Inspection Report
| Date | Inspector Name | Areas Inspected | Findings | Corrective Actions Required |
|---|---|---|---|---|
| 09/04/2025 | QA Supervisor | Cold Storage, General Warehouse | Humidity Control Issues | Adjust Humidifiers |
Annexure-7: Non-Conformance Report
| Date | NC Description | Area Affected | Reported By | Corrective Action |
|---|---|---|---|---|
| 09/04/2025 | Humidity exceeds limit | General Warehouse | QA Inspector | Calibrate Humidity Sensors |
Annexure-8: Corrective Action Log
| Date | NC Reference | Corrective Action Taken | Completed By | Completion Date |
|---|---|---|---|---|
| 09/04/2025 | NC-001 | Adjusted Humidifiers | Kiran Patel | 10/04/2025 |
Annexure-9: Inspection-Based Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 10/04/2025 | Sanjay Mehta | Proper Humidity Control | 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 |
| 09/04/2025 | 2.0 | Updated inspection checklists and added corrective action logs. | Regulatory Update | QA Head |