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
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