Glossary

Quality by Design

February 27, 2012

A two-fold program to [1] develop a pharmaceutical, biologic or medical device to meet predefined product quality, safety and efficacy specifications; and [2] design the manufacturing processes and controls around that pharmaceutical, biologic or medical device to meet predefined product quality, safety and efficacy specifications. Quality by Design begins in the preclinical, research and development phase, and carries forward through post-market and into retirement of the product. Non-medicinal influences that conceptualized Quality by Design started in the 1970s in the automotive, telecommunications and aeronautics industries.

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