|Standards Under Way Define Performance Quality Validation Procedures
for Thermal Analysis Methods
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 OToole, ASTM (610/832-9739). //
Copyright 2000, ASTM