The FDA guidance document; Reviewer Guidance Validation of Chromatographic Methods was issued by the Food and Drug Administration (FDA) in 1994 and provides recommendations on how analytical procedures and methods validation data can be submitted to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products, covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.
The guidance covers validation characteristics for specificity, linearity, accuracy, precision, range, quantitation limit, detection limit, and a variety of other validation parameters. While the standard covers specific areas of testing, it is meant to be a framework, instead of a list of required testing and specifications. Jordi’s chemists are experienced in applying ICH and FDA guidance when performing analytical method validation and can tailor an approach suitable to your application.