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GLP机构根据工作性质,设立机构办公室、质量保证部门、供试品室、临床检验室、动物实验室、病理室、遗传毒理室和档案室等部门,FM任命QAM,SD和各功能实验室负责人,根据各部门性质配备一般工作人员。具体岗位职责设置包括:FM、QAM、SDs、QAs、各部门负责人、实验员、饲养人员、供试品保管人、病理技术人员、兽医及其他人员。各人员岗位职责的具体内容依照药物非临床研究质量管理规范(2号令)要求,结合GLP机构性质制定并体现于相应的标准操作规程(SOP),其中,FM,QAM和SDs职责内容完全遵照2号令要求,其余人员岗位职责内容则根据2号令相关要求以及机构实际需要而定。GLP人员需定期参加培训,学习GLP法规及相应技术指导原则,掌握新技术和新方法。GLP人员培训形式包括岗前培训、定期培训、专题培训、技能培训、外出培训等,由于FM,QAM和部门负责人为直接任命,无针对性岗前培训,但参加其他形式培训,其余岗位工作人员均需参加所有形式的培训,且必须通过相应的职责考核才能获得GLP机构上岗证,具体考核形式包括理论和实际操作两部分内容。
According to the nature of the work, GLP institutes set up institutional offices, quality assurance departments, test rooms, clinical laboratories, animal laboratories, pathology rooms, genotoxicity rooms and archives and other departments. FM appointed QAM, SD and various function laboratories Responsible person, equipped with general staff according to the nature of each department. Specific job responsibilities include: FM, QAM, SDs, QAs, heads of departments, laboratory technicians, breeders, test samplers, pathologists, veterinarians and others. The responsibilities of each staff member shall be formulated and reflected in the corresponding SOPs in accordance with the requirements of the Quality Management Practices for Nonclinical Research in Pharmaceuticals (Order No. 2) and in accordance with the nature of the GLP institutions. Responsibilities of FMs, QAMs and SDs are fully complied with 2 Order requirements, the rest of the job responsibilities of staff positions are based on the order 2 and the actual needs of the relevant authorities. GLP personnel need regular training, learning GLP regulations and the corresponding technical guidelines, master new technologies and new methods. GLP personnel training forms include pre-job training, regular training, special training, skills training, out-going training, etc. As FM, QAM and department heads are directly appointed and unobtrusive pre-job training, they participate in other forms of training and the rest of staff All need to participate in all forms of training, and must pass the corresponding assessment of responsibility to obtain the GLP agency post card, the specific form of assessment includes theory and practical operation of the two parts.