Standard Operating Procedure for Environmental Monitoring

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for monitoring the microbial environment within the manufacturing facility 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.
• Environmental Monitoring Team: Responsible for conducting environmental monitoring activities as per this SOP.
• Facility Management: Responsible for providing necessary support and resources for environmental monitoring activities.

Procedure

1. Selection of Sampling Locations:
   • Identify critical sampling locations based on risk assessment, including areas with high traffic, potential sources of contamination, and critical processing zones.
2. Sampling Methods:
   • Use appropriate sampling methods (e.g., settle plates, air samplers, surface swabs) based on the nature of the environment and the parameters being monitored.
   • Follow aseptic techniques during sample collection to avoid contamination.
3. Frequency of Monitoring:
   • Establish a monitoring schedule based on regulatory requirements, historical data, and the risk associated with each area.
   • Regularly review and update the monitoring schedule as needed.
4. Sample Analysis:
   • Transfer collected samples to the microbiology laboratory for analysis without delay.
   • Perform microbial enumeration, identification, and trend analysis as per established methods and acceptance criteria.
5. Documentation and Reporting:
   • Document all environmental monitoring activities, including sampling locations, methods, results, and any corrective actions taken.
   • Report findings to relevant stakeholders and management for review and decision-making.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Environmental Monitoring Plan
• Sampling Location Map
• Environmental Monitoring Records

Reference

ICH Q9: Quality Risk Management

SOP Version

Version 1.0