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 2004 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.
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 environmental monitoring programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits and
The handling of excursions and what are some of the common deficiencies cited by regulatory auditors.
The webinar will also cover issues dealing with contamination control practices such as minimizing bio-burden levels, batch residuals, proper gowning requirements and personnel training. In addition, an actual case study of an EM excursion will be used to help attendees understand the depth of investigations expected; the decision process used to evaluate its impact on product produced and then will be given the opportunity to learn the agency's opinion on the investigation performed and their ruling. This has always been a favorite class exercise in past courses! The course will provide attendees the opportunity to ask questions or issues relating to their own environmental monitoring program.
Objectives of the Presentation:
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 can benefit:
This webinar will provide valuable assistance to all personnel in: QA/QC personnel, Manufacturing Engineering Validation Regulatory Management.