Procedure for Cross-Contamination Prevention During Dispensing

Department	Production/Quality Assurance
SOP No.	SOP/Ointment/007
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 define procedures for preventing cross-contamination during the dispensing of raw materials for ointment manufacturing. This ensures product integrity, compliance with Good Manufacturing Practices (GMP), and patient safety.

2. Scope

This SOP applies to all personnel involved in the dispensing of raw materials, including active pharmaceutical ingredients (APIs) and excipients, within the manufacturing facility. It includes guidelines on area segregation, equipment use, personnel hygiene, and cleaning validation.

3. Responsibilities

• Production Operator: Ensures proper handling of raw materials to prevent contamination.
• Quality Control (QC) Personnel: Conducts in-process checks to verify contamination control measures.
• Production Supervisor: Ensures compliance with cross-contamination prevention protocols.
• Quality Assurance (QA) Officer: Conducts audits and verifies adherence to contamination control practices.

4. Accountability

The Production Manager is accountable for implementing and ensuring compliance with cross-contamination prevention measures during dispensing.

5. Procedure

5.1 Environmental Controls

• Ensure that the dispensing area is segregated and maintained under controlled conditions.
• Use a dedicated dispensing booth with a unidirectional airflow system to minimize contamination.
• Monitor temperature, humidity, and airflow to ensure compliance with GMP standards.

5.2 Equipment Controls

• Use dedicated scoops, spatulas, and containers for different raw materials.
• Clean and sanitize weighing balances before and after each use.
• Ensure that weighing balances are properly covered when not in use.

5.3 Personnel Hygiene and Gowning

• All personnel must wear designated protective clothing, including gloves, masks, hairnets, and gowns.
• Change gloves and sanitize hands before handling each new material.
• Personnel must undergo training on contamination control measures.

5.4 Handling of Raw Materials

• Dispense one material at a time to avoid cross-contact.
• Ensure all materials are properly labeled and segregated.
• Use color-coded containers to differentiate raw materials.

5.5 Cleaning and Sanitation

• Follow the cleaning procedure for dispensing booths, weighing stations, and utensils.
• Record all cleaning activities in the Cleaning Log.
• Conduct periodic microbial and particle testing in the dispensing area.

5.6 Documentation and Record-Keeping

• Maintain logs for equipment use, material dispensing, and cleaning activities.
• Ensure all records are reviewed and approved by QA.
• Keep documentation updated and readily accessible for audits.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• API – Active Pharmaceutical Ingredient

7. Documents

• Cleaning Log (Annexure-1)
• Cross-Contamination Prevention Checklist (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	Equipment/Area Cleaned	Cleaning Agent Used	Cleaned By	Checked By
01/02/2025	Dispensing Booth	70% IPA	John Doe	QA Officer
02/02/2025	Weighing Balance	Distilled Water	Jane Smith	QA Officer

Annexure-2: Cross-Contamination Prevention Checklist

Date	Step Verified	Verified By	Comments
01/02/2025	Dedicated utensils used	QA Officer	Compliant
02/02/2025	Gloves changed before material handling	QA Officer	Compliant

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