Course overview
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.
Course learning outcomes
- Understand the evolution of current regulation of pharmaceutical manufacturing
- Appreciate the role of the regulatory authorities (TGA, FDA, EMA, etc) in ensuring pharmaceutical products and medical devices are safe and efficacious.
- Know how to implement validation to a pharmaceutical manufacturing unit operation and to an analytical technique used to measure pharmaceutical product quality
- Know how to implement Good Manufacturing Practice to pharmaceutical manufacturing
- Understanding the basics of hygiene, cleaning-in-place in pharmaceutical operations
- Understanding of the design considerations for pharmaceutical manufacturing facility design
- Know how to source regulatory guidance documents from the ICH and FDA