The United States Pharmacopeia (USP) states that method validation is done to make sure that analytical approach is precise, robust, repeatable, and accurate over the designated range that an analyte will be tested. Method validation, sometimes defined as the process of producing recorded proof that the method accomplishes its goals, offers a guarantee of dependability during routine use.
Method validation is a requirement for regulated laboratories to comply with FDA rules. In the Guidelines for Submitting Samples and Analytical Data for Publications. When assessing compliance with the Federal Food, Drug and Cosmetic Act, the FDA acknowledged the standards in the most recent edition of the USP as legally recognized (FDA 1987 Methods Validation). These requirements, which are referred to as the “eight steps of method validation,” are mentioned in USP Chapter and are relevant to method validation.
Author(s) Details:
V. Siddaiah,
Department of Chemistry, Andhra University, Visakhapatnam-530003, India.