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 (2) 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. FDA 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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