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
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The Student Contribution amount displayed below is for students commencing a new program from 2021 onwards. If you are continuing in a program you commenced prior to 1 January 2021, or are commencing an Honours degree relating to an undergraduate degree you commenced prior to 1 January 2021, you may be charged a different Student Contribution amount from the amount displayed below. Please check the Student Contribution bands for continuing students here. If you are an international student, or a domestic student studying in a full fee paying place, and are continuing study that you commenced in 2025 or earlier, your fees will be available here before enrolments open for 2026.