jester 发表于 2023-12-28 10:13:32

Quality Management Systems - Process Validation Guidance

Introduction
Purpose and scope
1.1 Purpose
1.2 Scope
Definitions
Processes that should be validated
3.1 Special processes
3.2 Process validation within the quality management syste m
3.3 Process validation decision
3.4 Examples
Statistical methods and tools for process validation
Conduct of a validation
5.1 Getting started
5.2 Protocol development
5.3 Installation qualification (IQ)
5.4 Operational qualification (OQ)
5.5 Performance qualification (PQ)
Maintaining a state of validation
6.1 Monitor and control
6.2 Changes in process and/or product
6.3 Continued state of control
6.4 Examples of reasons for revalidation
Use of historical data in process validation
Summary of activities
Statistical methods and tools for process validation
Example validation

lurenjia2011050 发表于 2023-12-28 12:49:58

感谢分享

JXPSCD1 发表于 2023-12-28 16:01:50

感谢分享！

16603768745 发表于 2023-12-28 17:20:44

这个是什么组织写的

me412 发表于 2023-12-28 20:00:59

感谢分享

zileo0617 发表于 2023-12-29 09:45:36

:handshake

golfgti 发表于 2023-12-29 10:08:24

謝謝分享

pdcicbt 发表于 2023-12-29 10:11:54

謝謝分享

布衣推理 发表于 2023-12-29 11:23:08

{:1_89:}

hying0306 发表于 2023-12-29 14:40:03

感谢分享！{:1_180:}
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