5 Compendial methods are verified rather than validated as described in section VI, C. 6 The terms drug substance and drug product are used in this guidance to refer to both human drugs and biologics. Information. considered during development and validation.

Should Compendial methods be validated?

Compendial testing methods are not required to be fully validated, but their suitability for testing should be verified under actual conditions of use. This requirement is established in 21 CFR 211.194(a)(2) of the current Good Manufacturing Practice regulations in the United States.

What are validated methods?

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.