Standard Operating Procedure for Microbial Contamination Control

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for preventing microbial contamination in the manufacturing environment of the pharmaceutical company.

Scope

This SOP applies to all areas within the manufacturing facility where pharmaceutical products are handled, processed, or stored.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Production Personnel: Responsible for adhering to the procedures outlined in this SOP during manufacturing operations.
• Facility Maintenance Team: Responsible for ensuring the cleanliness and sanitation of the manufacturing environment.

Procedure

1. Personal Hygiene:
   • All personnel must adhere to strict personal hygiene practices, including regular handwashing and the use of appropriate protective clothing (e.g., gowns, gloves, hairnets).
2. Environmental Monitoring:
   • Regular environmental monitoring of air, surfaces, and water sources must be conducted to detect and mitigate potential sources of microbial contamination.
3. Cleaning and Disinfection:
   • All manufacturing areas and equipment must be cleaned and disinfected according to established procedures and schedules.
   • Use only approved disinfectants and follow proper application techniques.
4. Material Handling:
   • Raw materials, intermediates, and finished products must be handled in a manner that minimizes the risk of microbial contamination.
   • Use dedicated equipment for handling sterile materials whenever possible.
5. Personnel Training:
   • All personnel involved in manufacturing operations must receive training on microbial contamination control procedures and adhere to them at all times.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Microbial Contamination Control Plan
• Facility Cleaning and Disinfection Schedule
• Training Records

Reference

Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach (FDA Guidance, 2004)

SOP Version

Version 1.0