The quality product leader (QPL), a single point of contact model, was created to manage the quality of clinical products and facilitate a new quicker-to-the-clinic approach to product development.  The purpose of the QPL is to provide quality oversight and a single and consistent quality approach of on CMC (chemistry, manufacturing and control) teams.  The QPL function enables efficient communication and decision-making as it relates to product quality.  The QPL performs many key quality tasks supporting GMP manufacturing, product testing and release, regulatory filings, and clinical supply.  The QPL acquires product-quality knowledge and acts as the quality expert for the product-quality history throughout the development cycle.  Those in the QPL role come from a broad range of backgrounds including QC, QA, analytical development and validation, or process development.

Quality product leader: Managing quality during clinical product development

244th National Meeting (2012)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.