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