Quality Committee GMP Case Study Meeting for FY2022

Program

Special Lecture

Revised GMP Ministerial Ordinance - Focusing on Recent Guidance Cases
Pharmaceuticals and Medical Devices Agency
Quality Control Section 1, Pharmaceutical Quality Control Department
Mr. Hiroki Kato

Case Presentations

Global Harmonization of Quality Assurance at Shionogi
Shionogi & Co.
Mr. Hideto Yamamoto

Efforts of Manufacturers and Distributors to Manage Manufacturers after the Revision of the GMP Ordinance - Manufacturer Audits at Shionogi & Co.
Meiji Seika Pharma Co.
Mr. Shigeru Ohta

Report on the results of a survey on pharmaceutical companies' efforts to comply with ICH Q3E (Extractables & Leachables for Pharmaceuticals)
E&L Project, Japan Pharmaceutical Manufacturers Association (JPMA)
Kissei Pharmaceutical Co.
Mr. Takashi Kurashima