Introduction to ICH :The Quality Guidelines :Q 2 – Analytical Validation

• Q 2 – Analytical Validation  

A guideline defining the validation parameters needed for a variety of analytical methods and describing characteristics to be considered for the validation of analytical procedures included in a marketing authorisation dossier.

• ICH Q 2 – ... In a Nutshell

Defines criteria for the validation of the four most common types of analytical procedures:

•  identification tests
• quantitative tests for impurities
• limit tests for the control of impurities
• quantitative tests for the active moiety in API or finished product or or other selected components in the product
• Defines typical analytical validation characteristics, to which tests to apply them and examples on the “how to”
• - Accuracy
• - Precision
• - Repeatability
• - Intermediate Precision
• - Specificity
• - Detection Limit
• - Quantitation Limit
• - Range