Procedure for Pre-Manufacturing Area Cleaning
| Department | Production/Quality Assurance (QA)/Housekeeping |
|---|---|
| SOP No. | PM-021 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for cleaning the manufacturing area before the commencement of production. Proper cleaning ensures compliance with Good Manufacturing Practices (GMP), prevents contamination, and maintains a hygienic work environment.
2. Scope
This SOP applies to all personnel responsible for cleaning and preparing the manufacturing area before the production of ointments. It includes cleaning of floors, walls, ceilings, equipment surfaces, and other critical areas.
3. Responsibilities
- Housekeeping Staff: Performs routine and deep cleaning of the manufacturing area.
- Production Supervisor: Ensures compliance with cleaning procedures before production starts.
- Quality Assurance (QA) Personnel: Inspects the cleaned area and approves the readiness of the facility.
- Maintenance Staff: Checks and verifies the condition of air handling units (AHUs) and drains.
4. Accountability
The Production and QA Managers are accountable for ensuring that the pre-manufacturing area cleaning is conducted as per regulatory requirements and that all cleaning activities are documented properly.
5. Procedure
5.1 Preparation for Cleaning
- Ensure all manufacturing personnel have vacated the area before cleaning.
- Wear appropriate personal protective equipment (PPE) such as gloves, masks, and gowns.
- Prepare approved cleaning agents and disinfectants as per standard guidelines.
5.2 Cleaning of Floors
- Sweep the floor to remove visible dust and debris.
- Mop the floor using a detergent solution and sterile water.
- Apply a disinfectant solution (e.g., 70% IPA) and allow it to air dry.
- Document cleaning activities in the Cleaning Log.
5.3 Cleaning of Walls and Ceilings
- Wipe walls with a lint-free cloth soaked in a mild detergent solution.
- Use a separate cloth soaked in disinfectant to sanitize wall surfaces.
- Ensure ceiling vents and light fixtures are free from dust accumulation.
5.4 Cleaning of Equipment Surfaces
- Wipe down all external surfaces of manufacturing equipment using a detergent solution.
- Disinfect critical contact surfaces with a validated disinfectant.
- Ensure no residues are left on surfaces before production starts.
5.5 Air Handling System and Drain Inspection
- Check that air handling units (AHUs) are functioning correctly.
- Inspect floor drains and remove any blockages.
- Report any maintenance issues to the engineering department.
5.6 Final Inspection and Approval
- QA personnel must inspect the area before production starts.
- Document the cleaning status and obtain approval from QA.
- Ensure that “Cleaned” status labels are displayed in the area.
6. Abbreviations
- PPE – Personal Protective Equipment
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- AHU – Air Handling Unit
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Checklist (Annexure-2)
- QA Inspection Report (Annexure-3)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide for APIs
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 Log
| Date | Area Cleaned | Cleaning Agent Used | Performed By | Verified By |
|---|---|---|---|---|
| 01/02/2025 | Manufacturing Room 1 | IPA 70% | John Doe | QA Officer |
| 02/02/2025 | Mixing Area | Disinfectant X | Jane Smith | QA Officer |
Annexure-2: Cleaning Checklist
| Area | Cleaning Task | Status (✔/✖) | Checked By |
|---|---|---|---|
| Floors | Mopping and Disinfection | ✔ | QA Officer |
| Walls | Dusting and Sanitization | ✔ | QA Officer |
| Equipment Surfaces | Wiping and Disinfection | ✔ | QA Officer |
Annexure-3: QA Inspection Report
| Date | Area Inspected | Cleaning Status | QA Remarks | Approved By |
|---|---|---|---|---|
| 01/02/2025 | Manufacturing Room 1 | Clean | Ready for production | QA Head |
| 02/02/2025 | Mixing Area | Clean | Ready for use | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |