Standard Operating Procedure for Cleaning and Sanitization of Raw Material Storage Racks
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/123/2025 |
| Supersedes | SOP/RM/123/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 21/02/2025 |
| Effective Date | 25/02/2025 |
| Review Date | 21/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the methods for cleaning and sanitizing raw material storage racks to prevent contamination, ensure product quality, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all storage racks in the raw material warehouse, including racks for APIs, excipients, solvents, and other raw materials.
3. Responsibilities
- Warehouse Personnel: Perform routine cleaning and sanitization of storage racks according to this SOP.
- Warehouse Manager: Supervise cleaning activities and ensure proper execution of procedures.
- Quality Assurance (QA): Verify cleaning records, conduct inspections, and ensure compliance with GMP guidelines.
4. Accountability
The Warehouse Manager is accountable for the execution of cleaning and sanitization procedures, while the QA Manager ensures compliance with regulatory standards and documentation accuracy.
5. Procedure
5.1 Cleaning Schedule
- Routine Cleaning:
- Clean storage racks weekly using approved cleaning agents.
- Perform additional cleaning after spills, product changes, or any contamination incidents.
- Document all cleaning activities in the Cleaning Schedule Log (Annexure-1).
- Deep Cleaning:
- Conduct deep cleaning of storage racks quarterly, including hard-to-reach areas.
- Disassemble racks if necessary to ensure thorough cleaning.
- Record deep cleaning activities in the Deep Cleaning Log (Annexure-2).
5.2 Cleaning and Sanitization Procedures
- Preparation:
- Remove all raw materials from the storage racks before cleaning.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, masks, and goggles.
- Ensure cleaning agents and sanitizers are approved by QA and compatible with stored materials.
- Cleaning Process:
- Dust and wipe down racks using lint-free cloths to remove loose particles.
- Apply cleaning agents to all surfaces and scrub using non-abrasive brushes.
- Wipe surfaces with clean water to remove any residue from cleaning agents.
- Document the cleaning process in the Cleaning Log (Annexure-3).
- Sanitization Process:
- Apply approved sanitizers to all surfaces, ensuring complete coverage.
- Allow sanitizers to air dry or wipe dry with sterile cloths, depending on the material compatibility.
- Document the sanitization process in the Sanitization Log (Annexure-4).
5.3 Post-Cleaning Inspection
- Visual Inspection:
- Conduct a visual inspection of the cleaned racks to ensure no residue or contaminants remain.
- Check for signs of rust, corrosion, or damage to the racks.
- Document inspections in the Post-Cleaning Inspection Log (Annexure-5).
- QA Verification:
- QA personnel must verify the cleaning and sanitization records and inspect selected racks.
- Document QA verification in the QA Verification Log (Annexure-6).
5.4 Handling of Deviations
- Deviation Reporting:
- Report any deviations, such as incomplete cleaning, improper sanitization, or damaged racks, immediately to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-7).
- Corrective Actions:
- Investigate the cause of deviations and implement corrective actions such as re-cleaning, replacing damaged racks, or retraining staff.
- Document corrective actions in the Corrective Action Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Cleaning Schedule Log (Annexure-1)
- Deep Cleaning Log (Annexure-2)
- Cleaning Log (Annexure-3)
- Sanitization Log (Annexure-4)
- Post-Cleaning Inspection Log (Annexure-5)
- QA Verification Log (Annexure-6)
- Deviation Log (Annexure-7)
- Corrective Action Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Cleaning and Disinfection Standards
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Schedule Log
| Date | Rack ID | Cleaning Performed By | Remarks |
|---|---|---|---|
| 21/02/2025 | Rack-01 | Ravi Kumar | Routine Cleaning Completed |
Annexure-2: Deep Cleaning Log
| Date | Rack ID | Deep Cleaning Performed By | Remarks |
|---|---|---|---|
| 15/02/2025 | Rack-03 | Sunita Sharma | Deep Cleaning Completed |
Annexure-3: Cleaning Log
| Date | Rack ID | Cleaning Agent Used | Performed By |
|---|---|---|---|
| 21/02/2025 | Rack-02 | 70% IPA | Anjali Mehta |
Annexure-4: Sanitization Log
| Date | Rack ID | Sanitizer Used | Performed By |
|---|---|---|---|
| 21/02/2025 | Rack-01 | Hydrogen Peroxide 3% | Ravi Kumar |
Annexure-5: Post-Cleaning Inspection Log
| Date | Rack ID | Inspected By | Findings |
|---|---|---|---|
| 21/02/2025 | Rack-01 | Sunita Sharma | No Residue Detected |
Annexure-6: QA Verification Log
| Date | Rack ID | Verified By | Remarks |
|---|---|---|---|
| 21/02/2025 | Rack-02 | Anjali Mehta | Verified and Approved |
Annexure-7: Deviation Log
| Date | Rack ID | Deviation | Reported By |
|---|---|---|---|
| 20/02/2025 | Rack-04 | Incomplete Cleaning Detected | Ravi Kumar |
Annexure-8: Corrective Action Log
| Date | Rack ID | Corrective Action Taken | Performed By |
|---|---|---|---|
| 20/02/2025 | Rack-04 | Re-cleaned and Inspected | 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 |
| 21/02/2025 | 2.0 | Updated Cleaning and Sanitization Procedures | Regulatory Compliance | QA Head |