Update of Japanese GMP Changes

Japanese Good Manufacturing Practices (JGMP) have undergone some modifications since the previous round in August 2021.

At the November GMP/GQP research meeting between the Pharmaceuticals and Medical Devices Agency and three state authorities, recent observations were classified as GMP deficiencies. There are two relevant guidances and one Q&A document available in Japanese.

1. GMP Ordinance issued on April 28, 2021
2. GMP Notification on April 28, 2021
3. GMP Case Study (Q&A) on April 28, 2022

Some new features in JGMP are:

• Suppliers of raw materials and packaging materials must be selected, qualified and periodically re-confirmed as to their effectiveness in meeting quality standards.
• Contract Organizations having an impact on product quality must be evaluated periodically for their effectiveness in meeting quality standards. Examples of these include companies responsible for: maintenance of buildings and equipment, calibration of gages, sterilizing or disinfection of clothing, and storage or processing of products, raw materials or packaging materials.
• Approved methods for manufacturing and testing must be followed and un-approved alternative methods not allowed.
• If Out of Trend tendencies are not monitored and controlled from the point of detection throughout the life of a study, a regulatory observation will be issued.

All four authorities have issued regulatory observations to those not following the above requirements for the control of suppliers and contract organizations.

There is on-going discussion between authorities and industry regarding alternative methods. An alternative test method is still allowed if it refers to a compendium method, Japanese Pharmacopeia, Japanese Pharmaceutical Codex, or Pharmaceutical excipient standards (GMP Notification). However, what if, in case of analytical equipment does not work and under repair, etc. are under discussion.