The following key points are addressed in this article:
- This discussion addresses physicochemical (non-animal) testing in good laboratory (GLP) facilities
- US Food and Drug Administration GLP regulations do not address physicochemical testing
- Environmental Protection Agency GLP regulations do address physicochemical testing
- EPA GLP regulations delete certain regulations more applicable to typical GLP animal testing from the physicochemical testing
- Stability of the analyte in the test articles under the test conditions should be known as a matter of good practice in any test setting
- The deletions employed by the EPA GLP effectively reduce GLP costs
- It is reasonable to apply the EPA GLP modifications to the FDA GLP for situations where physicochemical tests are performed.
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