Standard Operating Procedure for Environmental Monitoring in the Manufacturing Area
1) Purpose
The purpose of this SOP is to establish procedures for monitoring and controlling the environmental conditions within the pharmaceutical manufacturing area to ensure compliance with regulatory requirements and maintain product quality.
2) Scope
This SOP applies to all environmental monitoring activities conducted in the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Environmental Monitoring Team
- Perform routine monitoring of critical parameters such as air quality and surface cleanliness.
- Record and report monitoring results promptly to relevant personnel.
3.2 Quality Assurance (QA) Personnel
- Review environmental monitoring data for trends and deviations.
- Initiate corrective and preventive actions (CAPA) in response to environmental excursions.
4) Procedure
4.1 Monitoring Parameters
- Monitor airborne particulates, microbial levels, and temperature/humidity conditions.
- Conduct surface sampling for microbial contamination on critical surfaces.
4.2 Sampling Locations
- Select sampling locations based on risk assessment and regulatory requirements.
- Ensure representative sampling across different areas of the manufacturing facility.
4.3 Sampling Methods
- Use validated methods and equipment for air and surface sampling.
- Follow aseptic techniques during sample collection to prevent contamination.
4.4 Data Analysis and Reporting
- Analyze monitoring data for trends and deviations from established limits.
- Document findings in environmental monitoring records and notify relevant stakeholders.
5) Abbreviations, if any
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
- Environmental Monitoring Plan
- Sampling and Testing Protocols
- Environmental Monitoring Reports
7) Reference, if any
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
ISO 14644: Cleanrooms and associated controlled environments
8) SOP Version
Version 1.0