Procedure for Cleaning of Dispensing Booths

Department	Production/Quality Assurance
SOP No.	SOP/Ointment/008
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

This Standard Operating Procedure (SOP) outlines the process for cleaning dispensing booths used in the weighing and dispensing of raw materials for ointment manufacturing. The objective is to prevent cross-contamination, maintain a controlled environment, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for the cleaning and maintenance of dispensing booths. It includes routine and deep cleaning procedures, cleaning agent selection, and record-keeping.

3. Responsibilities

• Production Operator: Conducts cleaning as per the prescribed schedule.
• Quality Control (QC) Personnel: Inspects the cleaning process and verifies cleanliness levels.
• Production Supervisor: Ensures compliance with cleaning procedures.
• Quality Assurance (QA) Officer: Conducts periodic audits and ensures adherence to GMP.

4. Accountability

The Production Manager is accountable for ensuring that all dispensing booths are cleaned as per the defined standards and that records are maintained.

5. Procedure

5.1 Cleaning Frequency

• Routine cleaning: After each dispensing session.
• Deep cleaning: Weekly or as required based on risk assessment.
• Cleaning after spillage: Immediate cleaning in case of contamination.

5.2 Pre-Cleaning Preparations

• Ensure the booth is free from any raw materials before starting cleaning.
• Turn off power supply to any electrical equipment in the booth.
• Wear appropriate personal protective equipment (PPE), including gloves, masks, and safety goggles.
• Ensure that all required cleaning materials are available.

5.3 Routine Cleaning Procedure

• Use a lint-free cloth to wipe surfaces before applying cleaning agents.
• Clean all surfaces, including walls, weighing balances, and air filters, using 70% Isopropyl Alcohol (IPA).
• Ensure the floor and weighing platform are cleaned using a vacuum cleaner or mop with a disinfectant solution.
• Dispose of any waste materials in the designated hazardous waste disposal bins.

5.4 Deep Cleaning Procedure

• Remove detachable components such as air filters and clean them with a validated detergent.
• Clean hard-to-reach areas using a sterile mop or brush.
• Sanitize all surfaces using a validated disinfectant.
• Allow the booth to air-dry before resuming operations.

5.5 Cleaning Verification

• Inspect the booth after cleaning to ensure no residue is left behind.
• Perform swab testing on surfaces to check for microbial contamination.
• QC personnel must sign off the Cleaning Log once verification is complete.

5.6 Handling of Cleaning Equipment

• Ensure all cleaning tools are dedicated to the dispensing area.
• Store cleaning equipment in a designated area after use.
• Replace mops, cloths, and cleaning solutions as per the validation schedule.

5.7 Documentation and Record-Keeping

• Maintain Cleaning Logs for each dispensing booth.
• Record the cleaning date, time, and personnel involved.
• Ensure that cleaning records are reviewed and approved by QA.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• IPA – Isopropyl Alcohol

7. Documents

• Cleaning Log (Annexure-1)
• Cleaning Verification Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7: Good Manufacturing Practice Guide

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	Booth ID	Cleaning Agent Used	Cleaned By	Verified By
01/02/2025	Booth-01	70% IPA	John Doe	QA Officer
02/02/2025	Booth-02	Validated Disinfectant	Jane Smith	QA Officer

Annexure-2: Cleaning Verification Report

Date	Booth ID	Surface Swabbed	Test Performed	Result	Verified By
01/02/2025	Booth-01	Weighing Table	Microbial Count	Pass	QA Officer
02/02/2025	Booth-02	Airflow Grille	Particle Count	Pass	QA Officer

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP	QA Head	All	All	Created new SOP
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head	All	All	Revised to meet new documentation standards