Method Validation : A Part from The Book Chapter : Analytical Method Validation Parameters (USP/ICH)

The process of confirming through laboratory testing that an analytical procedure’s performance characteristics match the demands for the planned analytical applications is known as validation. Method validation, sometimes known as “the process for providing documented evidence that the method does what it is intended to do,” offers a guarantee of reliability during regular use. The primary goal of the validation process is to show that the analytical method is accurate, specific, and precise within the designated range for the analyte being tested, and that it is appropriate for the intended use. Analytical Approach Validation must be carried out for both new and existing analysis methods whenever modifications are made to the process or the medication product’s composition. Common types of analytical procedure that can be validated.

Author(s) Details:

V. Siddaiah,
Department of Chemistry, Andhra University, Visakhapatnam-530003, India.

To Read the Complete Chapter See Here

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