工艺验证
过程(计算)
计算机科学
术语
系统工程
过程开发
工艺工程
过程分析技术
过程管理
在制品
生化工程
制造工程
风险分析(工程)
软件工程
工程类
验证和确认
运营管理
医学
操作系统
哲学
语言学
作者
Neal G. Anderson,David C. Burdick,Maxwell M. Reeve
摘要
Process validation includes laboratory optimization, pilot-plant introduction, and process implementation on manufacturing scale, as well as monitoring batches after implementation and continuously improving the manufacturing processes. There are many opportunities to change and optimize operations. The background information in this contribution describes current guidance and terminology for validation, including the integration of validation over the development lifecycle of drug substances. Various examples illustrate challenges and success stories of implementation as part of the overall approach to process validation.
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