GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring is a tool that looks at the end results of the Environmental Control program. This would access the environmental conditions in particular the microbiological and particulate quality of the pharmaceutical clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program 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.” Thus, it is important to have ongoing environment monitoring program of a clean room environment to ensure the quality and safety of the pharmaceutical product. Also, from a compliance perspective, having proper understanding of international regulatory standards and testing of the clean room environment is vital.

Why You Should Attend:

This webinar will first discuss the various clean room classification as well as the various US and international regulatory requirements that apply. Environmental monitoring requirements and best practices will be discussed. Furthermore, the webinar will details the benefits and the testing requirements for a comprehensive Environmental Monitoring Program. Our trainer will provide a description of how to establish Action and Alert Levels as well as how these levels are determined for a particular facility. Additionally, the session will aim to define corrective and preventative actions and review all current air monitoring systems for the measurement of non-viable particulate. We will also take a look at all current air and surface monitoring systems for the measurement of microbial contaminants in the clean room in detail. You will also get a sound understanding of clean room contamination due to personnel, including both gowning technique and aseptic practices

Areas Covered in the Session :

• Understanding Cleanroom
• Environmental Monitoring vs. Environmental Control
• GMP Regulations
• Environmental Monitoring Program
  • Benefits
  • SOPs
  • Testing Requirements
  • Regulatory Classifications
  • Personnel Microbial Monitoring
• Microbiological Media Controls
• Microbiological Monitoring Programs
• Sterile Isolator and Closed RABS Technology
• Investigation of Alert/Action Level Excursions
• Release of Product

Who Should Attend:

• Quality Departments
• Environmental Monitoring Departments
• Microbiology
• Manufacturing Departments
• Validation Departments
• Engineering Departments
• Maintenance Departments

Course Director: ROGER COWAN ‎

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing.  He has 37 years experience in pharmaceutical quality assurance and manufacturing.  In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution.  Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada. Roger’s areas of expertise include:  aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.