Good Laboratory Practice(GLP,良好实验室规范)是一套国际通用的质量管理体系,旨在规范非临床研究的操作流程,确保
This study presents findings from Good Laboratory Practice (GLP) inspections in Japan. In Japan, GLP inspections of facilities that test pharmaceuticals and medical devices are coordinated by the Office of the Conformity Audit of the Pharmaceuticals and Medical Devices Agency (PMDA). All of the ...
This study presents findings from Good Laboratory Practice (GLP) inspections in Japan. In Japan, GLP inspections of facilities that test pharmaceuticals and medical devices are coordinated by the Office of the Conformity Audit of the Pharmaceuticals and Medical Devices Agency (PMDA). All of the appl...
laboratory information management system pharmaceutical R&D pharmacy research and development MDD medical device directive EU Directive CRA clinical research associate CTA clinical trial authorisation IND CFR FDA MHRA EMA PMDA asthma COPD oncology cancer CNS central nervous system investigator site audit TMF ...
FDA, EU, PMDA and Federal Ministry of Health. Guilin Pharma's 1 production line of oral solid formation and 3 injection production lines passed the WHO- PQ certification. Yaopharma's 1 production line of oral solid formation passed the certification of FDA of US and Health department of ...
This study presents findings from Good Laboratory Practice (GLP) inspections in Japan. In Japan, GLP inspections of facilities that test pharmaceuticals and medical devices are coordinated by the Office of the Conformity Audit of the Pharmaceuticals and Medical Devices Agency (PMDA). All of the ...