Regulatory Management for Japan
- Management of Japan-specific requirements in Marketing Authorisation Procedures
- Establishment of Regulatory Documentation for and from Japan, International Challenges
- Japanese oriented Organisation and Structures in Drug Regulatory Affairs
Regulatory Requirements in Japan
- Japanese Pharmaceutical Authorities
- Development of Japanese Pharmaceutical Law
- Japanese System of Law
- Revised Pharmaceutical Affairs Law (r-PAL)
- GMP Regulations in Japan (J-GMP)
„Japan Quality“ – Specific Requirements for Oral Solid Dosage Forms
- Typical defects and their potential origin
- Defect classification from a Japanese point of view
- Organisational measures in a multi purpose production environment
- Potential improvement measures to minimize defect occurrence
Specific Japan Requirements Regarding Analytical Testing
- Pharmacopoeias in Japan (JP, JPE, JPC, JPED)
- JP requirements on APIs and excipients
- Specific requirements for analytical methods (method description, test procedure, method validation, specific test methods)
- Harmonisation
„Japan Quality“ – Specific Requirements for Liquid/Sterile Dosage Forms (Parenterals)
- Case studies within Parenterals manufacturing
- Implemented measures in aseptic production
- Increasing requirements for primary packaging materials
- Stragies to reduce unnecessary rejects in visual inspection
„Quality for the Japanese Market“ – The Special Requirements for Secondary Packaging Materials
- General expectations to folding cartons and inserts
- Defect evaluations of printing and finishing issues
- Development of a defect list specification
- Strategy of the packaging material producers
- Realisation in the daily practice