The GLPs apply to the chemical procedures used to characterize the test article, to
determine the stability of the test article and its mixtures, and to determine the homogeneity
and concentration of test article mixtures. Likewise, the GLPs apply to the chemical
procedures used to analyze specimens (e.g. clinical chemistry, urinalysis). The GLPs do not
apply to the work done to develop chemical methods of analysis or to establish the
specifications of a test article.