解説
医薬品固形剤製造プロセスにおける安定生産への取組み
2016 年 53 巻 9 号 p. 564-570
詳細
2016 年 53 巻 9 号 p. 564-570
Demand on generic drug is being increased recently, and high quality level and stable supply are required to generic pharmaceutical company as well as innovative pharmaceutical company. To achieve that, implementation of ICH Q trio is necessary. Implementation of ICH Q trio should be considered in R&D development phase, but for legacy product, it has to be done in production phase. PAT and QbD approach support these challenge on legacy product. At this time, several examples are introduced about how to achieve these challenges in Takayama plant of Teva.
