GXP

Establishing an Environmental Monitoring Oversight Committee

In recent years there has been an increased emphasis by regulatory investigators on the need for a system that encourages senior management involvement in environmental monitoring and sterility assurance programs.  For companies manufacturing sterile products, usually this is in the form of some type of Sterility Assurance Oversite Program.  For companies manufacturing non-sterile products this may be an Environmental Monitoring Oversite Committee.  Establishment of this type of committee was identified as part of an environmental monitoring program. This paper describes the reasons or purpose of these types of committees and what some of the functions of these committees are.

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