治験薬GMPに基づいた臨床試験用院内無菌製剤室の設置と適合性評価

概要

論文の詳細を見る
Translational research is important for applying the outcomes of basic researches to practical medical treatments. In exploratory clinical trials in the early-phase for an innovative therapy, researchers should often manufacture investigational agents by themselves. To supply investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Fifteen manuals about the production management and quality control were enacted. Staff organization based on the enacted manuals was also designated. The facility, manuals and staff organization were evaluated according to good manufacturing practice (GMP) for investigational new drugs (INDs). They were revealed to conform to GMP for INDs except for some clauses. Furthermore, the management of microparticles and microorganisms in the sterile room, referring to the Japanese Pharmacopeia, was determined, and the cleanness was evaluated. A manufacturing facility complying with GMP for INDs was established for supplying high-quality sterile drugs in clinical studies. These achievements can contribute to the safety of patients and reliability in clinical studies.
日本医療薬学会の論文