Standard Operating Procedure for Cleaning and Maintenance of Raw Material Storage Areas
Department | Warehouse / Quality Assurance |
---|---|
SOP No. | SOP/RM/117/2025 |
Supersedes | SOP/RM/117/2022 |
Page No. | Page 1 of 15 |
Issue Date | 17/02/2025 |
Effective Date | 21/02/2025 |
Review Date | 17/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the cleaning and maintenance protocols for raw material storage areas to ensure a clean, contamination-free environment in compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw material storage areas within the warehouse, including general storage zones, temperature-controlled rooms, hazardous material sections, and quarantine zones.
3. Responsibilities
- Warehouse Personnel: Perform routine cleaning, report maintenance issues, and ensure cleanliness standards are upheld.
- Quality Assurance (QA): Inspect and verify the cleanliness and maintenance status of storage areas.
- Warehouse Manager: Supervise cleaning and maintenance activities, ensure staff are trained, and coordinate repairs.
4. Accountability
The Warehouse Manager is accountable for implementing cleaning schedules and ensuring maintenance protocols are followed, while the QA Manager ensures compliance through inspections and audits.
5. Procedure
5.1 Cleaning Schedule and Frequency
- Daily Cleaning:
- Sweep floors, remove dust, and dispose of any waste material
at the end of each shift.
Wipe down high-touch surfaces such as door handles and light switches with disinfectant.
Document activities in the Daily Cleaning Log (Annexure-1).
Weekly Cleaning:
Monthly Deep Cleaning:
- Clean storage racks, pallets, and shelving units using appropriate cleaning agents.
- Check for and remove any pest infestations or mold growth.
- Document weekly activities in the Weekly Cleaning Log (Annexure-2).
- Conduct deep cleaning of the entire storage area, including walls, ceilings, and ventilation systems.
- Use approved cleaning agents that are non-reactive with stored materials.
- Document deep cleaning activities in the Monthly Deep Cleaning Log (Annexure-3).
5.2 Cleaning Procedures
- General Cleaning Protocol:
- Wear Personal Protective Equipment (PPE) as required, including gloves, masks, and protective clothing.
- Use designated cleaning equipment (e.g., mops, brooms, vacuums) for specific storage zones to prevent cross-contamination.
- Ensure all cleaning agents are labeled and stored separately from raw materials.
- Spill Management:
- Immediately clean any spills using appropriate spill kits and notify the Warehouse Manager.
- Document spills and corrective actions in the Spill Cleaning Log (Annexure-4).
5.3 Maintenance of Storage Areas
- Routine Maintenance:
- Inspect storage racks, shelving units, and pallets weekly for structural integrity.
- Ensure temperature and humidity control systems are functioning correctly.
- Document routine maintenance activities in the Maintenance Log (Annexure-5).
- Repairs and Replacements:
- Report damaged racks, flooring, or environmental control systems immediately to the Warehouse Manager.
- Coordinate with maintenance teams to repair or replace faulty equipment.
- Document all repairs and replacements in the Repair Log (Annexure-6).
5.4 Handling of Deviations
- Deviation Detection:
- Identify deviations such as unclean surfaces, pest infestations, or malfunctioning equipment during routine checks.
- Isolate affected areas and materials to prevent contamination.
- Document deviations in the Deviation Log (Annexure-7).
- Corrective Actions:
- Initiate immediate corrective actions, including re-cleaning, fumigation, or equipment repair.
- Document corrective actions in the Corrective Action Log (Annexure-8).
5.5 Verification and Compliance Monitoring
- QA Inspections:
- QA will conduct monthly inspections to verify cleaning and maintenance activities.
- Document inspection findings in the QA Inspection Log (Annexure-9).
- Compliance Audits:
- Conduct quarterly compliance audits to ensure adherence to GMP standards.
- Document audit results in the Compliance Audit Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Daily Cleaning Log (Annexure-1)
- Weekly Cleaning Log (Annexure-2)
- Monthly Deep Cleaning Log (Annexure-3)
- Spill Cleaning Log (Annexure-4)
- Maintenance Log (Annexure-5)
- Repair Log (Annexure-6)
- Deviation Log (Annexure-7)
- Corrective Action Log (Annexure-8)
- QA Inspection Log (Annexure-9)
- Compliance Audit Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Standards for Workplace Safety
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 | Area Cleaned | Cleaning Method | Performed By |
---|---|---|---|
17/02/2025 | General Storage Area | Sweeping and Dusting | Ravi Kumar |
Annexure-2: Weekly Cleaning Log
Date | Area Cleaned | Cleaning Method | Performed By |
---|---|---|---|
17/02/2025 | Storage Racks | Wiping with Disinfectant | Sunita Sharma |
Annexure-3: Monthly Deep Cleaning Log
Date | Area Cleaned | Cleaning Method | Performed By |
---|---|---|---|
01/02/2025 | Entire Warehouse | Deep Cleaning with Approved Agents | Anjali Mehta |
Annexure-4: Spill Cleaning Log
Date | Spill Type | Area Affected | Action Taken | Performed By |
---|---|---|---|---|
15/02/2025 | Chemical Spill | Hazardous Storage Area | Used Spill Kit and Ventilated Area | Ravi Kumar |
Annexure-5: Maintenance Log
Date | Equipment/Area | Maintenance Activity | Performed By |
---|---|---|---|
16/02/2025 | Temperature Control System | Filter Replacement | Anjali Mehta |
Annexure-6: Repair Log
Date | Area Repaired | Issue | Repair Details | Performed By |
---|---|---|---|---|
14/02/2025 | Storage Rack | Bent Support | Reinforced Rack Structure | Sunita Sharma |
Annexure-7: Deviation Log
Date | Deviation | Corrective Action | Reported By |
---|---|---|---|
13/02/2025 | Unclean Floor Detected | Re-cleaned Area | Ravi Kumar |
Annexure-8: Corrective Action Log
Date | Issue | Corrective Action Taken | Performed By |
---|---|---|---|
12/02/2025 | Pest Infestation | Fumigation | Ravi Kumar |
Annexure-9: QA Inspection Log
Date | Area Inspected | Findings | Corrective Actions | Inspected By |
---|---|---|---|---|
10/02/2025 | General Storage Area | No Issues Detected | N/A | Anjali Mehta |
Annexure-10: Compliance Audit Log
Date | Audit Type | Findings | Corrective Actions | Audited By |
---|---|---|---|---|
01/02/2025 | Storage Area Cleaning Audit | Compliant | N/A | Anjali Mehta |
Revision History:
Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
---|---|---|---|---|
01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
17/02/2025 | 2.0 | Updated Cleaning and Maintenance Procedures | Regulatory Compliance | QA Head |