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JVT Article: A Step-by-Step Approach to Establishing a Method Validation Program

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Item Number: JA0Q8076
Author: Cindy Green

The information in this article is intended to provide a systematic approach for establishing a method validation program. There are a variety of product types that require some level of evaluation and testing either at the raw material, intermediate, or final product level. There is no question that critical decisions may be made based on these test results and therefore, it is logical that one must strive to ensure the accuracy and reproducibility of these results. Recognizing that all of us desire to achieve a high level of confidence in the reported results, we must also be mindful that there are many types of assays used for a broad range of reasons. All assays used for all purposes do not require the same level of validation. It is important to be able to proceed logically through the rationale that selects not only which assay should be validated, but how that assay should be validated. This article attempts to provide the guidance for making these two primary decisions.

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