Abstract
In drug development, Good Laboratory Practice (GLP) regulations define the principles to assure the quality and integrity of nonclinical laboratory studies conducted to support development and commercialization of regulated therapeutic products. The Test and Control Articles section of the GLP regulations covers an important aspect relating to the conduct of nonclinical safety studies and is often the source of scientific, technical and/or, compliance issues on studies. One of the critical elements to ensure the validity of a study in assessing the safety profile of an investigational product, is to use a material that is relevant and representative of the intended material to be tested in humans or ultimately commercialized. One of the most popular and common questions that comes up regularly in our practice is if the Test Article used for a GLP-compliant nonclinical safety study must be manufactured according to GMP or not.
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