GMP Environmental Monitoring for Pharmaceutical Clean Rooms

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.

Why Should You Attend:

As per FDA Guideline on Aseptic Processing GMP (2004) one of the most important laboratory controls is the environmental monitoring program which provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.

Hence a proper understanding and testing of the clean room environment and ongoing environmental monitoring of a clean room environment is necessary from a product compliance perspective.

Areas Covered in the Webinar:

• GMP Compliance of Clean Room Environment
• Regulatory Clean Room Classification and Requirements
• Environmental Monitoring Program
• Action and Alert Levels
• Non-Viable Particulate Monitoring Systems
• Microbial Monitoring Systems
• Personnel Gowning and Aseptic Practices in Clean Room

Frequently Asked Questions:

1. What's the difference between a building automation system and an environmental monitoring system?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Assurance
• Environmental Monitoring
• Microbiology
• Manufacturing
• Validation