Requirements for Method Type

Methods for the quantitation of major components of bulk drug substances or APIs, including preservatives, in finished drug products are classified in Category I. Assay and content uniformity methods fall into this category. These methods demonstrate that the label claim of the drug 

TABLE 2 Validation Requirements for Each Type of Analytical Method 

Validation parameter Assay Category 1 Assay Category II Quantitiative Assay Category II Limit test Assay Category III Identification 

Category II methods are intended to determine impurities in bulk drug substance, degradation products in finished drug product, or for verification of cleaning processes. These methods are further subdivided into quantitative tests and limit tests. 

In the case of limit test, no quantitation is involved. A sample is run against a standard prepared at the specification level. The response of the sample is determined to be either above or below the standard amount and the results either pass or fail the specification. The LOQ is not required for this method type, but the LOD is needed. Specificity is the only other parameter required for validation, although accuracy and range may be determined depending on the nature of the method. 

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