Validation of tests methods in the quality control of biologicals.

Abstract

With increasing frequency new methods are being developed for the assessment of the quality of biological products. Before these methods can be considered for regulatory acceptance, their relevance and reliability must be established in a formal validation study. Such a study should be tailor-made, depending on the particular purpose and goal of the new method. However, a set of general principles can be given, according to which a validation study should be conducted. Essential ingredients in a validation study are the three Cs for Common sense, Commitment and Communication. Common sense in the design of the study, Commitment of the participating laboratories and Communication between the parties involved. An overview will be given of the various stages of a validation study, the time period needed (Table 1) and a number of problems that can be encountered will be discussed.