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Physicochemical Testing and the GLPs
Author: Steven S. Kuwahara

“GLP Forum” addresses topics of interest associated with good laboratory practices. We intend this column to be a useful resource for daily work applications. The key objective for the column: Useful information.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Manuscripts or case studies submitted by readers are welcome. Please send your comments and suggestions to column coordinator Steven Kuwahara at stevekuwahara@yahoo.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
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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