Physicochemical Testing and the GLPs | IVT


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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