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QC(quality control)是为达到非临床研究质量要求所采取的具体操作技术和实施的行为,是贯穿GLP始终的发现问题、寻求问题原因和解决方法,并最终解决问题的过程。在GLP中实施QC,能够与QA互相促进并提高质量控制水平,保证GLP质量的可溯性。QC是对非临床研究的中间操作和最终结果进行检验,看是否符合GLP的要求。实施QC的人员为从事研究的人员,属于内部控制。关键环节必须100%QC,QC过程常分为两种,一种是试验过程的QC,另一种是试验文件的QC。QC可纳入每项研究工作中,以保证数据的可追踪和验证,所有试验部门均应有全部原始数据核查过程及提交给QA审查前的QC处理步骤。需要有一定的QC要求和核查的SOP。QC须由参与关键工作的称职人员来完成,并按程序向有关责任人报告。每项QC检查需提供相应的文字证据,包括QC实施者签名,QC实施的日期,检查事项及检查方法等。所遵循的原则为“无书面记录就不承认有关行为发生过”。
Quality control (QC) is a technique that is used to achieve the quality of non-clinical research. It is a process of discovering problems, finding causes and solutions, and finally solving problems throughout GLP. Implementing QC in GLP can promote each other with QA and improve quality control to ensure the traceability of GLP quality. QC tests the interoperability and end-results of nonclinical studies to see if they meet GLP requirements. The personnel who carry out QC are the personnel who are engaged in the research and belong to the internal control. The key link must be 100% QC, QC process is often divided into two kinds, one is the QC of the test process, the other is the test file QC. QC can be incorporated into every research effort to ensure traceability and verification of data. All testing departments should have full raw data verification processes and QC pre-submission QC procedures. Need to have some QC requirements and verification SOP. The QC shall be completed by competent personnel who are involved in the key tasks and shall be reported to the relevant responsible persons according to the procedure. Each QC inspection shall be accompanied by written evidence, including the signature of the QC implementer, the date of QC implementation, inspection items and inspection methods. The principle followed was “no written record does not recognize the conduct occurred”.