Collaboration between the quality management and analytical development groups plays a key role in developing and obtaining regulatory agency approval for new pharmaceutical products.  This presentation will provide an overview of the quality aspects of pharmaceutical development, and details of the interface between the two groups.  Some of the aspects to be discussed are an introduction to the regulations, a brief overview of the pharmaceutical development process, and the quality by design concept.  Focusing on the interface, the process for releasing supplies for clinical trials will be presented, including examples of investigations.  Current and future challenges will also be discussed.

Analytical development and quality management – an essential interface in pharmaceutical development

244th National Meeting (2012)

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