Process Validation SOP - TEMPLATE (Technical Series on Process Validation Principles and Practices Book 2)

This e-document is presented in the form of a standard operation procedure for validation of medical device manufacturing processes. It covers elements of process validation, determining the scope of process validation, protocol and report development and strategy for maintaining the validation state.

Also included are the use of historical data in process validation, application of process equivalency in process validation and process revalidation requirements.