Standard Operating Procedure for Periodic Cleaning and Inspection of Raw Material Storage Units
| Department | Warehouse / Quality Assurance / Housekeeping |
|---|---|
| SOP No. | SOP/RM/138/2025 |
| Supersedes | SOP/RM/138/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 07/03/2025 |
| Effective Date | 14/03/2025 |
| Review Date | 07/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes the guidelines for periodic cleaning and inspection of raw material storage units to ensure a clean, contamination-free, and compliant environment in accordance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all storage units, including shelves, racks, bins, and cabinets used for storing raw materials such as Active Pharmaceutical Ingredients (APIs), excipients, solvents, and chemicals within the warehouse.
3. Responsibilities
- Warehouse Personnel: Perform routine cleaning and visual inspections of storage units.
- Housekeeping Team: Conduct scheduled deep cleaning of storage areas using approved cleaning agents.
- Warehouse Manager: Supervise cleaning activities and ensure that all inspections are documented properly.
- Quality Assurance (QA): Verify cleaning effectiveness and approve the use of cleaned storage units.
4. Accountability
The Warehouse Manager is accountable for ensuring that all raw material storage units are cleaned and inspected periodically. The QA Manager is responsible for verifying compliance with GMP
standards.
5. Procedure
5.1 Routine Cleaning Procedures
- Daily Cleaning:
- Warehouse personnel must perform daily dusting and removal of visible debris from storage units using clean, lint-free cloths.
- Ensure no raw materials are directly exposed during cleaning; cover materials as needed.
- Document daily cleaning activities in the Daily Cleaning Log (Annexure-1).
- Weekly Cleaning:
- Conduct thorough weekly cleaning using approved disinfectants. Focus on frequently touched areas such as handles and doors.
- Inspect for any spillage or contamination and take corrective action if needed.
- Record weekly cleaning activities in the Weekly Cleaning Log (Annexure-2).
5.2 Deep Cleaning and Disinfection
- Monthly Deep Cleaning:
- Schedule monthly deep cleaning of all storage units, including removing stored materials temporarily to clean the entire area.
- Use GMP-compliant cleaning agents and ensure the storage units are completely dry before returning materials.
- Document deep cleaning in the Deep Cleaning Log (Annexure-3).
- Post-Cleaning Inspection:
- QA personnel must inspect the cleaned storage units to ensure no residues or contaminants remain.
- Approve the cleaned areas for use and document inspections in the Post-Cleaning Inspection Log (Annexure-4).
5.3 Inspection of Storage Units
- Routine Visual Inspection:
- Inspect storage units for signs of rust, damage, or wear that may compromise raw material integrity.
- Check for signs of pest activity, moisture, or contamination.
- Document visual inspections in the Storage Unit Inspection Log (Annexure-5).
- Corrective Actions for Damaged Units:
- In case of identified damage, remove affected units from service and initiate repair or replacement.
- Document corrective actions in the Corrective Action Log (Annexure-6).
5.4 Documentation and Record Keeping
- Record Maintenance:
- Maintain all cleaning and inspection records for a minimum of five years.
- Ensure records are readily available for internal audits and external inspections.
- Document record retention in the Record Retention Log (Annexure-7).
- Review and Continuous Improvement:
- QA should review cleaning and inspection logs quarterly and suggest improvements if necessary.
- Record reviews and updates in the Cleaning Procedure Review Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
7. Documents
- Daily Cleaning Log (Annexure-1)
- Weekly Cleaning Log (Annexure-2)
- Deep Cleaning Log (Annexure-3)
- Post-Cleaning Inspection Log (Annexure-4)
- Storage Unit Inspection Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- Record Retention Log (Annexure-7)
- Cleaning Procedure Review Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- ISO 14644-1: Cleanrooms and Associated Controlled Environments
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Daily Cleaning Log
| Date | Storage Unit | Cleaning Method | Performed By | Remarks |
|---|---|---|---|---|
| 07/03/2025 | Rack A1 | Dusting with lint-free cloth | Ravi Kumar | No issues |
Annexure-2: Weekly Cleaning Log
| Date | Storage Unit | Cleaning Agent Used | Performed By | Verified By |
|---|---|---|---|---|
| 05/03/2025 | Cold Storage Shelf B2 | 70% Isopropyl Alcohol | Neha Verma | Priya Singh |
Annexure-3: Deep Cleaning Log
| Date | Storage Unit | Cleaning Agent Used | Method of Cleaning | Performed By | Verified By |
|---|---|---|---|---|---|
| 01/03/2025 | API Storage Rack C1 | Disinfectant Solution (GMP-Approved) | Wiping and Drying | Amit Joshi | Priya Singh (QA) |
| 01/03/2025 | Excipients Storage Cabinet D3 | 70% Isopropyl Alcohol | Spray and Wipe | Neha Verma | Rajeev Menon (QA) |
Annexure-4: Post-Cleaning Inspection Log
| Date | Storage Unit | Inspection Findings | Status | Inspected By |
|---|---|---|---|---|
| 01/03/2025 | API Storage Rack C1 | No residues, clean and dry | Approved for Use | Priya Singh (QA) |
| 01/03/2025 | Excipients Storage Cabinet D3 | Minor moisture detected, re-drying required | Re-cleaned and Approved | Rajeev Menon (QA) |
Annexure-5: Storage Unit Inspection Log
| Date | Storage Unit | Condition Observed | Corrective Action Needed | Inspected By |
|---|---|---|---|---|
| 02/03/2025 | Solvent Storage Rack E5 | Rust formation on lower shelves | Rust removed, anti-corrosive applied | Ravi Kumar |
| 02/03/2025 | API Storage Cabinet F4 | Clean and intact | None | Neha Verma |
Annexure-6: Corrective Action Log
| Date | Issue Identified | Corrective Action Taken | Performed By | Verified By |
|---|---|---|---|---|
| 02/03/2025 | Rust on Solvent Rack E5 | Removed rust, applied anti-corrosive paint | Amit Joshi | Priya Singh (QA) |
| 03/03/2025 | Moisture in Excipients Storage | Re-dried storage unit, adjusted humidity controls | Ravi Kumar | Rajeev Menon (QA) |
Annexure-7: Record Retention Log
| Date | Document Name | Retention Period | Stored By | Storage Location |
|---|---|---|---|---|
| 03/03/2025 | Deep Cleaning Log | 5 Years | Priya Singh (QA) | Document Control Room A |
| 03/03/2025 | Post-Cleaning Inspection Log | 5 Years | Rajeev Menon (QA) | Document Control Room B |
Annexure-8: Cleaning Procedure Review Log
| Date | Review Type | Findings | Recommendations | Reviewed By |
|---|---|---|---|---|
| 05/03/2025 | Quarterly Review | Cleaning frequency adequate, no major issues | Continue current schedule | Priya Singh (QA) |
| 05/03/2025 | Annual Review | Humidity control improvements needed | Install dehumidifiers in high-risk areas | Rajeev Menon (QA) |
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 |
| 07/03/2025 | 2.0 | Updated cleaning frequency and inspection protocols | Improved compliance with GMP standards | QA Head |