Analytical Methods

An analytical technique to determine a specific propterty of a sample

Defined in PDA TR57 Analytical Method Validation and Transfer for Biotechnology Products as "That which is performed in order to obtain a reportable result. The procedure should describe in detail the steps necessary to perform the analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generations of the calibration curve, use of the formulae for the calculation". Analytical methods is a synonym for analytical procedures. In the context of cleaning, a validated analytical method is used to determine the effectiveness of the cleaning process and confirm that the cleaning parameters are successful (or fail) at reducing target residues to the acceptance limit. USP <1225> Validation of Compendial Methods outlines the required characteristics for an analytical method to be validated.