A Step-by-Step Guide for Method Validation
What is Validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry
Validation is a process-risk will determine the effort
For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=slideserve-ppt
High Risk:Total validation
Moderate Risk:Testing,Documentation
Low Risk:Testing the change
Validation of Analytical Methods-Key Steps
Preparation
Experimentation
Transfering Method
Documentation
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