ABSTRACT
The USP informational Chapter <1196>, Pharmacopeial Harmonization, provides information about the concept of harmonization by the PDG, which was formed in 1989. The PDG has representatives from the European Directorate for the Quality of Medicines in the European Council, the United States Pharmacopeial Convention, and the Japanese Pharmacopoeia in the Ministry of Health, Labor, and Welfare (MHLW), and it often meets in conjunction with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The goal of harmonization is to reduce the burden on the part of pharmaceutical manufacturers of performing a test in different ways and using
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different acceptance criteria to prove that a particular product complies with speci-cations for a given quality attribute. The compendial tests for microbial attributes of nonsterile products fall in this category and needed harmonization so that users could achieve conformity to specications while performing a single test.
