ABSTRACT
OBJECTIVES Regulators are expected to evaluate a wide range of manufacturing and test methods as part of their responsibility to safeguard the public health. Concerns of regulatory authorities with respect to changes in test methods in the pharmaceutical industry include the scientific validation of the new methods and correlation of their results with the results from standard or “classical” methods. These concerns become very difficult to weigh objectively in the area of microbiological tests because of the technical variability inherent in some of these tests and the high level of variability in sampling. This issue is addressed more completely in Chapter 12, (on validation), and it is the subject of PDA (Parenteral Drug Association) Technical Report 33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods,” May/June 2000. Because most of these assays are related to purity, potency, or safety of pharmaceutical products, regulatory agencies view them as critical. Agencies require scientific evidence in support of validation and use of these methods.
