The Regulatory Expectations for Environmental Monitoring Programs

Why Should You Attend:

The establishment of environmental monitoring programs is critical to the success of aseptic, terminal sterilization and non-sterile manufacturing facilities as it is a tool for evaluating the adequacy of cleaning programs, personnel gowning and contamination control practices.

This course will focus on three major points:

• The regulatory requirements for environmental monitoring
• The main issues with EM programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits
• The handling of excursions and some of the common deficiencies cited by regulatory auditors

The webinar will also discuss issues dealing with contamination control practices such as minimizing bio-burden levels, batch residuals, proper gowning requirements and personnel training.

In addition, the webinar will cover recent revisions to ISO 14642-1 and 2 and how they impact environmental monitoring programs and practices. The course will provide attendees the opportunity to ask questions or issues relating to their own environmental monitoring program.

Areas Covered in the Webinar:

• Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
• Discuss the issues of sampling methods, selection of sampling sites and the justifications for them
• Review the issue of contamination control as an important aspect of EM programs.
• Discuss the issue of action and alert limits, trending of data and the handling of excursions to them.
• What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
• Attendee question and answer period.

Who Will Benefit:

• Quality Assurance
• Quality Control
• Manufacturing
• Production
• Regulatory
• Laboratory Personnel
• Management
• Equipment vendors

Kenneth Christie
Chief Operating Officer, VTS Consultants Inc

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member. He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Topic Background:

Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced. The purpose of the EM program is to document the state of control of the facility, not to determine the quality of the finished product.

The US Food and Drug Administration guidance document on sterile drug products is very clear on this point in section X.A.I and 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. The environmental monitoring program established by companies is an area of major focus during regulatory audits of sterile products as well as a source of many deficiencies. Environmental monitoring also involves the monitoring of personnel, establishment of sampling sites and type, setting limits and the handling of excursions when they occur.

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