Recommended best practice for method validation

The intention of this section is to provide a framework for validation, not a comprehensive set of requirements. It should be regarded as a minimum. The implementation of a validation exercise should be customised for each application and the documented intent contained in a validation or verification protocol as outlined in NMLK No. 4.  

The United States Pharmacopoeia identifies three categories of assay. 

I Analytical methods for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products. 

Analytical performance parameter I Quantitative Limit tests III 

II Analytical methods for determination of impurities in bulk drug substances or degradation products in finished pharmaceutical products. 

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