文档介绍：北方药学 2012 年第 9 卷第 8 期 87
医院制剂室实施设备前验证流程的探讨
孟永钦周虔唐英健(江苏省苏州大学附属儿童医院苏州 215003)
摘要:目的:通过前验证,合理的论证和监控医院制剂室从设备采购到投入实际生产的全过程。方法:对设备前验证中各环节的
工作进行细分或合并。结果与结论:增加前验证可操作性,使医院制剂室有能力开展设备验证工作。医院制剂室应从实际情况出
发制定合理的前验证方案,可有效地提高引进设备的实用性和降低固定资产投资风险。
关键词:医院制剂室设备前验证
中图分类号:R95 文献标识码:B 文章编号:1672-8351(2012)08-0087-02
To discuss the hospital preparations department implement equipment prospective validation of flow path
Meng Yongqin Zhou Qian Tang Yingjian(Children’s Hospital Affiliated to Soochow University Suzhou 215003,China)
Abstract:Objective:Through prospective validation,rational demonstration and monitoring The department of hospital preparations
from equipment procurement to put into the whole process of practical : Prospective validation of each section of
work subdivided or merge execution. Results & Conclusions: Increase operation ability,Make of the hospital pharmaceutical
preparation has the ability to carry out equipment validation. In accordance with the actual situation,the hospital preparations
department set up reasonable Prospective validation,Can effectively increase the practicability of importing the equipments reduce
fixed assets investment risk.
Key word:The hospital preparations department Equipment Prospective validation
随着我国对医院制剂配制日益严格的要求和规范[1],以及量差异要求来确定, 其精度原则上应不大于质量标准规定装
医院制剂室自身发展的需要, 医院制剂室经常会引进一些设量差异的一半。 c 设备可拆卸程度和难易度。好