Pharmacopeias with International Conference

Founded in 1990, the International Conference on Harmonization (ICH) is comprised of the pharmacopeial manufacturers associations in Europe (EFPIA), Japan (JPMA), the United States (PMA), and the drug regulatory agencies in Europe (EEC), Japan (MHW), and the United States (FDA), with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) serving as secretariat. Pharmacopeias are not members of the ICH, where membership is reserved for three PMAs and three regulatory agencies. Invited observers include Canada, WHO, and the European Free Trade Association (EFTA). 

Two organizations account for harmonization of new and revised standards the Pharmacopeial Discussion Group (PDG) and the International Conference on Harmonisation (ICH). Primary impact is attributed in this cycle again to the PDG consisting of the USP with the Japanese and European pharmacopeias. Joint open conferences held on an international basis were crucial to any progress here because these ensured direct contact among experts from the three pharmacopeias (see Open Conferences and Meetings, earlier). 

Storage conditions should be specified on the label of API containers when it is critical to maintain such conditions to ensure the quality of the API. Where applicable, labeled storage conditions should comply with standard definitions for Freezer, Cold, or Controlled Room Temperature, as defined in the United States Pharmacopeia (USP) or guidelines of the International Conference on Harmonisation (ICH). Statements of specific storage conditions should be used instead of more general terms such as room temperature when it is critical for maintaining the quality of APIs. 

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