Policy: Good Laboratory Practices Advisories - Compliance Monitoring

The laboratory inspection/data audit program monitors the regulated community, who periodically raise questions related to the interpretation of the Good Laboratory Practices (GLP) regulations. Inspectors and other interested personnel have also asked EPA for guidance on the regulations.   Often the questions are relatively simple and straight forward to which all inspectors would provide a uniform and consistent reply.  However, there are instances when several interpretations are possible or clarification may be necessary. The purpose of the advisories is to provide that clarification.

What follows are interpretations of the GLP regulations as issued by the Office of Compliance.  This interpretation is official policy in the GLP program and should be followed by all GLP inspectors.

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