论文部分内容阅读
根据《药品质量监督检验工作管理暂行规定》国药监市[2001]388号文件精神及各地药品监督管理局药品年度抽验工作计划,各地药品监督管理分局的药品质量监督抽验工作正在紧张有序地按计划实施展开。然而新组建的药监分局和新划转的基层药检所,由于新机构,人员新,对抽验工作不够熟悉,加之对药学专业知识掌握不足等原因,在实际抽验工作的操作过程中,逐渐暴露出一些问题。不能根据实际需要较准确地计算和确定抽验量,机械照搬全检抽样量,造成抽样量不足,更
Pursuant to the spirit of the document of “State Drug Administration [2001] No. 388” and the annual drug sampling work plan of drug administrations across the country, Interim Regulations on the Administration of Drug Quality Supervision and Inspection, the drug quality supervision and sampling work of drug administrations across the country is under intense and orderly According to the plan to carry out. However, the newly established drug regulatory branch and the newly transferred primary drug administration, due to new institutions, new staff, the work is not familiar with the sampling test, combined with lack of knowledge of pharmacy expertise and other reasons, the actual sampling operation gradually exposed Some problems. Can not calculate and determine the test quantity more accurately according to the actual needs, and mechanically copy the whole sample quantity, resulting in insufficient sample quantity and more