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质量保证部门(QAU)就是负责实验质量保证的单位。质量保证程序在GLP规范中是一个独立于研究团队之外的文件记录系统,其目的是确保非临床研究机构的设施、设备及实验的运行管理符合GLP的要求,它的运行机制是监督每一项研究,确保研究是按照SOP的要求进行。QAU在明确自己的职责或任务后,则要按照程序和要求履行职责,QAU必须检查每项研究和在任何可能的时候进行检查,而不应该事先通知实施研究的人员,检查时要尽量不干扰正常试验,为做到这一点QAU工作人员可以对每一个检查阶段设计出一个检查表,表要简明,检查完毕后要写出完整的检查报告。对总结报告的审查也是QAU最重要并且耗费时间的工作。审查是要确保报告正确地描述所采用的方法和准确的反映原始资料,在进行总结报告的稽查中必须记住QAU不能以任何方式对原始资料进行科学解释,因为这是专题负责人的责任。另外QA不能帮助研究人员改正错误及由该错误引起的一系列错误,QA只能发现错误,并提出改正的建议,尽量减少从原始资料到总结报告的错误率是QAU的责任。其要点如下:
Quality Assurance Department (QAU) is responsible for the quality assurance unit of the experiment. The Quality Assurance Program is a separate documentation system independent of the research team in the GLP Code. Its purpose is to ensure that the operations, facilities and equipment of nonclinical research institutes and their operations are managed in accordance with the requirements of GLP. Its operation mechanism is to supervise each Study to ensure that research is conducted in accordance with SOP requirements. After QAU has defined its responsibilities or tasks, it must perform its duties according to the procedures and requirements. The QAU must examine each study and examine it whenever possible, without prior notification to the person conducting the study, and try not to interfere with the inspection Normal test. In order to do this, QAU staff can design a checklist for each check phase. The table should be concise, and a complete check report should be written after the check is completed. The review of the summary report is also the most important and time-consuming exercise at QAU. The review is to ensure that the report correctly describes the methodology used and accurately reflects the source. It must be kept in mind during the audit of the summary report that the QAU can not scientifically interpret the source material in any way as this is the responsibility of the thematic leader. In addition QA can not help researchers to correct errors and a series of errors caused by the error, QA can only find errors, and make corrective suggestions to minimize the error rate from the source to the summary report is the QAU’s responsibility. The main points are as follows: