“Quality initiatives, such as those by the U.S. Food and Drug Administration and the U.S. Pharmacopeia, now require performance validation of methods under their jurisdiction,” said Roger Blaine, chair of ASTM Subcommittee E37.01 on Thermal Analysis Method. “This validation is sometimes called ‘performance qualification’ or ‘PQ’ in other quality programs. The FDA and USP provide only generalized suggestions for performing method or apparatus validation.”

To assist thermal analysis users as they perform this requirement, a standard description of the validation procedure is being drafted by Subcommittee E37.03 on Nomenclature and Definitions in Committee E37 on Thermal Measurements.

Blaine anticipates the first draft of this procedure will be submitted for subcommittee ballot during the first quarter of 2001. “The final effort will involve the terminology of validation terms, as these terms are often different than those commonly used in ASTM standards,” Blaine added.

This activity will be followed by the development of a proposed standard validation procedure by Subcommittee E37.01 on Test Methods and Recommended Practices that describes a method and apparatus based on differential scanning calorimetry (DSC). According to Blaine, balloting on the DSC validation procedure is expected to begin in mid-year 2001.

Anyone wishing to participate in either activity should contact Roger Blaine. For Committee E37 meeting or membership details, contact Staff Manager Tom O’Toole, ASTM (610/832-9739). //

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