CHEM ENG 7063 - Good Manufacturing Practice, Validation and Regulation

North Terrace Campus - Semester 2 - 2024

The aim of this course is to introduce the strategy for producing high quality safe pharmaceutics. This module will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). The concepts of quality by design (QbD), process analytical technology (PAT) and continuous manufacturing will be introduced. Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines.

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