Standard Operating Procedure for Cross-Contamination Prevention

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures and guidelines for preventing cross-contamination between samples or products in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in sample handling, processing, and manufacturing operations within the pharmaceutical facility.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Production Supervisors: Responsible for ensuring that personnel adhere to cross-contamination prevention procedures during manufacturing operations.
• Quality Control (QC) Inspectors: Responsible for monitoring manufacturing processes to detect and prevent instances of cross-contamination.

Procedure

1. Segregation of Materials:
   • Segregate materials, equipment, and personnel based on their intended use and risk of cross-contamination.
   • Designate separate areas or zones for handling different products or materials to minimize the risk of cross-contact.
2. Proper Cleaning and Sanitization:
   • Implement robust cleaning and sanitization procedures for equipment, surfaces, and production areas.
   • Use validated cleaning agents and methods to effectively remove residues and microorganisms that could lead to cross-contamination.
3. Equipment and Tool Management:
   • Implement procedures for dedicated use and cleaning of equipment and tools to prevent cross-contamination.
   • Label equipment and tools clearly to indicate their designated use and prevent mix-ups.
4. Personnel Hygiene Practices:
   • Enforce strict hygiene practices among personnel, including hand washing, use of personal protective equipment (PPE), and adherence to gowning procedures.
   • Provide training to personnel on the importance of preventing cross-contamination and the proper use of hygiene facilities and equipment.
5. Sampling and Testing Protocols:
   • Establish clear protocols for sampling and testing to ensure that samples are handled and analyzed in a manner that minimizes the risk of cross-contamination.
   • Use separate sampling tools and containers for different materials or products to prevent contamination between samples.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

Documents

• Cross-Contamination Prevention Plan
• Cleaning and Sanitization Records
• Personnel Training Records

Reference

United States Pharmacopoeia (USP) General Chapter Good Manufacturing Practice

SOP Version

Version 1.0