Process Validation Articles
Accoding to US FDA, Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
Process Validation: How Much to Do and When to Do It
The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.
For full article Click Here
Journal:
BioPharm International, October 2002
Copyright:
BioPharm International
