论药品检测实验室的质量监督工作

目的提高药品检测实验室对质量监督工作的认识,有效利用质量监督促进实验室质量管理体系的不断改进、完善和提高。方法依据相关准则的规定、质量监督员的职责、质量监督记录表的编制等要求,对药品检测实验室质量监督工作进行分析探讨。结果相关准则对质量监督有着非常明确的要求,实验室应从人员、环境条件、实验过程等方面进行策划和实施质量监督。结论为发挥质量监督员的监督作用,避免质量监督流于形式,实验室应赋予质量监督员足够的权力;建立和完善实验室质量监督机制,形成一套有效的质量监督记录表格,从而保证检测结果的准确可靠。

Discussion on Quality Supervision on the Drug Testing Laboratory

Objective To improve the recognition of the quality supervision on the laboratory and promote the quality supervision efficiency to perfect the quality system.Methods According to related principles,several aspects of laboratory quality supervision work were analyzed,including responsibilities of quality supervisors,the standard of quality supervision record tables etc.Results Related principles had very clear requirements on quality supervision.Quality supervision should cover all aspects including staff,environmental conditions,testing process etc.Conclusion To ensure the accuracy of testing results,effective supervision system and standard record tables should be formed,and quality supervisors should be fully empowered to carry out supervision.