Formulation and Quality – Chemical
2019 PharmSci 360
Suitability of all testing methods is required to be verified under actual conditions of use, and this requirement is established in 21 CFR 211.194(a)(2) of the current Good Manufacturing Practice regulations in United States. Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories but documented evidence of suitability should be established under actual conditions of use. In addition, ANVISA also requires that compendial analytical methods shall have their suitability demonstrated for the intended use by a partial validation study. Partial validation must evaluate at least for the parameters of precision, accuracy and specificity. Examples of suitability verification for several compendial methods (e.g. sub-visible particles color and clarity/opalescence) and challenges faced will be presented.