What is an Analytical Test Method Validation?

Is the verification that the process and instructions used to confirm that the analytical test method procedure employed for a specific test is suitable and validated for its intended use.  The analytical test method validation is described in the USP and other reference documents.

The United States Pharmacopeia (USP) <1225> defines method validation as “a process by which it is established, through laboratory studies, that the performance characteristics of a method meet the requirements for its intended analytical applications.”

Results from method validation can be used to judge the quality, reliability, and consistency of the analytical results.

It is an integral part of any good laboratory practice (GLP) because brings trust to the reported results.

The FDA definition of the Analytical Test Method Validation

The FDA guidelines define a Methods Validation: “Establishing documented evidence that provides a high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.”

Statutory and Regulatory Requirements – Analytical Test Method Validation

Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.

The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical products with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in the USP and the NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use.

Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for the adoption of new or revised compendial analytical methods be supported by sufficient laboratory data to document their validity.