摘要
随着科学技术的迅速发展,如今有越来越多的制药厂开始将自动化控制操作系统运用到生产药物的过程之中,各道工序的进行都离不开计算机系统的操作。因此,计算机化系统慢慢变成了制药项目中一个不可或缺的重要组成部分。在将计算机化控制系统运用到验证中前,首先要考虑清楚该使用何种方式,采用什么程序。本文就无菌配液的自动化系统作为典例,讲解应该如何按照GAMP5的概念特性将制药设备的自动化系统运用到实际的验证过程中。此外,还简单介绍了系统从开发到使用的完整过程和与＂规范、验证＂相关的内容。
With the rapid development of science and technology,more and more pharmaceutical factories begin to apply the automatic control operation system to the production of drugs. The operation of every process is inseparable from the operation of computer system. As a result,computerized systems have gradually become an indispensable part of the pharmaceutical project. Before applying the computer control system to the verification,we should first consider what way to use and what program to use. In this paper,the automatic system of sterile dispensing is taken as an example to explain how to apply the automation system of pharmaceutical equipment to the actual verification process according to the concept characteristics of GAMP5. In addition,the complete process of the system from development to use and the content related to ＂ specification and verification＂ are also introduced.
作者
周晓华
ZHOU Xiaohua(Xi＇an Medical University,Information Technology Office,Shanxi Xi＇an,710021)
出处
《自动化与仪器仪表》
2018年第8期23-25,共3页
Automation & Instrumentation
