Quality Systems - Pharmaceutical/Drug GMP Audits in Japan

In Japan, Good Manufacturing Practice (GMP) for drugs is referred to as Japanese GMP, or J-GMP. Other Japan-specific pharmaceutical/drug quality standards include the following: Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).

Finding updated, official translations of GMP is difficult. Many times English versions will not have the latest version and understanding the nuances can be tricky. To ensure full compliance, having experts such as PBM who have access to the original Japanese regulations and to the MHLW is essential. Oftentimes, regulations can be vague and clarifications with the MHLW/PMDA will be necessary.

PBM can audit your pharmaceutical/drug facility in Japan to make sure it complies with all the Japanese standards and also international standards. Even if a facility complies with international standards, that does not mean it complies with stringent Japanese standards.

For more information on Japanese pharmaceutical/drug quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.

Japan Quality Audits 2010 (publication for sale)
Contract Research Organizations in Asia 2011 (publication for sale)
Orphan Drugs in Asia: Guidelines and Regulatory Requirements 2011 (publication for sale)
Foreign Manufacturer Accreditation for Drugs in Japan (webcast for sale)
Doing Business in Japan (webcast for sale)