• Yakugaku Zasshi · Jan 2020

    Review

    [Contributions of the Japanese Pharmacopoeia to the Quality of Generic Pharmaceuticals].

    • Ken-Ichi Izutsu.
    • Division of Drugs, National Institute of Health Sciences.
    • Yakugaku Zasshi. 2020 Jan 1; 140 (6): 773-776.

    AbstractThe rapid increase in the use of ethical generic pharmaceutical formulations in Japan emphasizes the importance of measures to ensure the quality of pharmaceutical distribution. This short review discusses the contributions of the Japanese Pharmacopoeia (JP) to pharmaceutical quality control. Numerous monographs have defined specifications and tests for multiple active pharmaceutical ingredients and excipients. Standardized methods of performing general tests and reference standards allow efficient, reliable evaluation of pharmaceutical quality during development processes and commercial manufacturing. Some new methods of characterizing the structure and performance of nonbiological complex drugs have been included in recent editions. An introduction to general tests and general information regarding the control of impurities in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines should significantly reduce the safety risks of pharmaceuticals.

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