品質リスクマネジメントに関するガイドラインの改正（案）に対するパブリックコメントの募集
FDA Plans to Issue Part 11 Q&A Guidance
FDA U.S. inspections resumed
Manufacturing and Quality Control Systems at Pharmaceutical Manufacturers
Three requirements for authenticity
Differences in regulatory requirements between Europe, the U.S. and Japan
Importance of Fast Time to Market
PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS（対訳）