Case Study 48: GMP Quality Audit of CMO in Japan

Company Situation

The client is a European pharmaceutical company that didn’t have any presence in Japanese market but has to conduct local clinical studies with their new oncology drug before its registration with PMDA in Japan.
The client was looking for local quality auditor who can qualify a local CMOs (contract manufacturing organization) in Japan, before to hiring him as the primary and secondary packaging site of their investigational products in Japan that will be used in Japanese clinical studies.

GRP Solution

Global Regulatory Partners ,Inc has qualified Japanese GMP auditors who can perform GMP quality audits in Japan according to the following regulation and standards: Japanese Ordinance #169(QMS) and Japanese Ordinance #179 (GMP)

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