title: [Accession to the PIC/S and pharmaceutical quality system in Japan].
abstract: In March, 2012, Japan made the application for membership of the Pharmaceutical Inspection convention and Pharmaceutical Inspection Co-operation scheme (PIC/S) which is an international body of a GMP inspection. The globalization of pharmaceutical manufacturing and sales has been a driving force behind the decision to become a PIC/S member. For the application for membership, Japan's GMP inspectorate needs to fulfill PIC/S requirements, for example, the inspection organization has to have a quality system as a global standard. One of the other requirements is that the GMP inspectorate can access Official Medicines Control Laboratories (OMCL) having high analytical skills and also have a quality system based on ISO 17025. I would like to describe the process to make up a quality system in the National Institute of Health Sciences and also the circumstances around the PIC/S application in Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Katori
mesh_terms: D004345:Drug Industry / Q000592:standards*; D016903:Drug Monitoring; D006077:Government Agencies / Q000458:organization & administration; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006298:Health Services Administration; D006801:Humans; D007391:International Cooperation; D007564:Japan; D004364:Pharmaceutical Preparations / Q000592:standards*; D060735:Pharmacovigilance; D011786:Quality Control; D012308:Risk Management
chemical_list: D004364:Pharmaceutical Preparations