Analytical Method Development and Validation

Analytical method developmentquality assurance <span style="&quot;color:" rgb(51,="" 51,="" 51);="" font-family:="" "roboto="" slab",="" serif;="" font-size:="" 13px;="" text-align:="" justify;="" background-color:="" rgb(255,="" 255,="" 255);"="">departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It supports in formation of product-specific acceptance criteria and stability of results. Validation should establish that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and validation. 

 

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