For Human Life and Health, Keep the Quality
－その品質をより確かなものにするために－
The GLP division investigates quality assurance for non-clinical studies. Major study themes are i) GLP regulations related to drugs, medical devices,agricultural chemicals, chemical substances and so on, ii) quality management for non-GLP studies and iii) computer systems used in non-clinical studies.
The GLP division also has regional study groups which discuss any topics related to quality assurance for non- clinical studies in Eastern and Western Japan. This does not include study groups which focus on one of the above-mentioned themes.
The GCP division addresses the latest selected problems and issues an order to improve the knowledge and the skill levels of the members engaged in quality assurance of clinical studies, standardize interpretations through information sharing and present suggestions to member companies and relevant parties. The main focused areas are quality management system, methodology of auditing, computerized system, relationship among stake holders of clinical studies and inspection by health authorities. It also provides a variety of training courses for QC/QA personnel of member companies.
The GQP/GVP/GPSP division works to improve levels of quality and quality management as defined by MHLW ordinances on GQP (Good Quality Practice),GVP (Good Vigilance Practice) and GPSP (Good Post-marketing Study Practice). The main focused areas are self-inspection techniques, QA techniques in GQP, GMP, GVP and GPSP operations, investigation of the cases of inspection by regulatory authorities, education of personnel in charge of self-inspection.