Manufacturing and Quality Control Systems at Pharmaceutical Manufacturers
Three requirements for authenticity
Differences in regulatory requirements between Europe, the U.S. and Japan
Is verification unnecessary with validation?
Importance of Fast Time to Market
Is ISO 13485 certification required?
PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS（対訳）
Good Distribution Practice For Medicinal Products For Human Use, Questions And Answers, Version 1.0（対訳）