News about GMP/cGMP

14.04.2022

Japanese Pharmacopeia with English Translation

Japanese Pharmacopeia with English Translation

The Japanese MHLW (Japanese Minister of Health, Labour and Welfare) has released the 18th Edition of the Japanese Pharmacopoeia (JP) as an English translation for download free of charge.


The 18th edition came into effect on June 7, 2021, and consists of

  • General Notices,
  • General Rules for Crude Drugs,
  • General Rules for Preparations,
  • General Tests, Processes and Apparatus and
  • Official Monographs
  • General Information

Being an official document, it defines the specifications, criteria and standard test methods necessary to properly assure the quality of medicines in Japan. The document is revised periodically with a further edition being planned for the year 2026.


Source:

MHLW: Website

PMDA:  Japanese Pharmacopoeia


 

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