Purpose

An overview of Good Manufacturing Practices, targeted to those participating in research and development, is essential to the process of late-stage development of any critical material that is intended for use in an in vitro diagnostic, a pharmaceutical, a medical device, or any of an entire host of other applications that are regulated by the U.S. Food and Drug Administration (FDA).

While most of the Code of Federal Regulations (CFR) and the Points to Consider provide guidance for the finished diagnostic kit (or finished pharmaceutical, etc.), it is necessary to begin detailed record-keeping and other practices in the latter stage of research and development in order to meet the increasingly strict regulations for historical development information and traceability to the source of such critical materials.

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