2023 Volume 58 Issue 1 Pages 26-35
Purpose: The World Health Organization (WHO) published Good Pharmacopoeial Practices, the Pharmacopoeial Discussion Group (PDG) has been harmonizing excipient monographs and general chapters, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published quality guidelines. In addition to these activities, pharmacopoeial harmonization is desired to supply high-quality pharmaceutical products while effectively utilizing limited resources. The ICH proposes a method to promote the harmonization of pharmacopoeias around the world by investigating a preparation and revision process use for General Notices in the Japanese Pharmacopoeia (JP), which is an initial member of the PDG, as an example. Method: The authors investigated the preparation and revision history of the JP, established versions for the 49 General Notices in the current JP 18th edition, and the JP General Notices that were established or revised referencing the contents of the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and ICH guidelines. Results: The JP was prepared and revised with references to the pharmacopoeias of the Netherlands, United Kingdom, France, Germany, and the United States. Some JP General Notices were established or revised while referring to the contents of the USP, Ph. Eur., and ICH guidelines. Conclusion: It is believed that the preparation and revision process of the JP, such as the prompt incorporation of contents from other countries' or regions' pharmacopoeias into the JP after having a thorough understanding, and flexibility revising any issues, makes the JP worthy of being a reference for other countries' pharmacopoeias.
