浅谈授权签字人对药品检验报告的审核

Discussion on the Audit of Authorized Officers on Drug Testing Reports

目的探讨药品检验报告书授权签字人履行审核职责有关问题,为提高检验报告审核质量和审核效率提供参考。方法从授权签字人的职责、审核方法、审核经验和技巧等方面,对药品检测实验室的检验报告审核工作进行探讨。结果实验室授权签字人应从记录、人员、仪器、环境条件、检验过程等方面实施审核。结论授权签字人应探索审核程序和方法,明确审核范围,把握审核进度,做好分类审核,提高检验报告审核质量和审核效率。

Objective To discuss the relevant issues of authorized audit responsibilities of the drug inspection report. To improve the audit quality and efficiency as well as provide a reference for inspection reports. Methods The audit work of drug testing reports from laboratories was discussed, including authorized officers＇ responsibility, audit methods, and audit experience and skills. Results Laboratory authorized officers should conduct the audit on several aspects including record, personnel, equipment, environmental condition and test process. Conclusion Authorized officers should improve the audit quality and efficiency by perfecting audit procedures and methods, defining the scope of audit, grasping the progress and conducting the classification audit.