Pharmacopeial Harmonization: A Progress Report

Abstract

A major effort in pharmacopeial harmonization began when the heads of the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP) formed a voluntary alliance, the Pharmacopeial Discussion Group (PDG), in September 1989. After some experience with harmonization, PDG developed a five-stage harmonization procedure with the additional adoption and implementation stages and initiated the Lead Pharmacopeia System. The current status of more than 50 articles including excipient monographs and test methods is summarized. A number of articles are at the proposal and official inquiry stages. These two stages are the most time consuming because all comments are considered and agreements and disagreements are communicated through public forums. A case study dealing with the harmonization of the Stearic Acid monograph which is at the proposal stage of harmonization is discussed to illustrate the type of complex issues that need resolution for harmonization to succeed.

Keywords

Pharmacopeial Harmonization

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