Quality & Technology Committee GMP Case Study Group for 2007
Japan Pharmaceutical Manufacturers Association Quality & Technology Committee Pharmaceutical Publication Center
Program
Special Lecture
- Cooperation" between Marketing and Manufacturing - Change Control and Deviation Control - (258KB)
Dear Mr. Hidemoto Kazama, GMP Guidance Officer, Supervisory Guidance and Drug Control Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
- (Venue: Osaka) Information sharing of matters pointed out in the revised GMP - Notes on matters pointed out in GMP in Osaka Prefecture - (296KB)
Mr. Shinichi Shimada, Deputy Chief, Pharmaceutical Production Group, Pharmaceutical Affairs Division, Health and Welfare Department, Osaka Prefectural Government
- (Tokyo Venue) GMP Conformity Surveys on Pharmaceuticals Conducted by the Tokyo Metropolitan Government (299KB)
Mr. Masahiro Hirai, Chief, Pharmaceutical Surveillance Section 3, Pharmaceutical Surveillance and Guidance Division, Wide Area Surveillance Department, Tokyo Metropolitan Health and Safety Research Center
Case Study Presentations
- Cooperation" between marketing and manufacturing - Based on three concrete examples - (650KB)
Mr. Nobutoshi Kojima, Manager, Quality Assurance Department, NIPPON SHINYAKU Co., Ltd.
- Coordination of changes and deviations in manufacturing and sales - Case studies of LIMS updates - (944KB)
Mr. Hiroaki MIYAZAWA, Production Planning Section, Production Planning Department, Production Division, KISSEI PHARMACEUTICAL CO., LTD.
- Computer systemization of change management operations (196KB)
Mr. Hideo Otsuki, Manager, Quality Assurance Group, Pharmaceutical Quality Assurance Department, Dainippon Sumitomo Pharma Co.
- Claims system in our company (1.9MB)
Mr. Fumiyoshi Moriyama, Manager, Quality Planning & Information Group, Quality Assurance Department, Quality Assurance Division, Reliability Assurance Division, CHUGAI PHARMACEUTICAL CO.