Course overview
This course aims to introduce the strategy for producing high quality safe pharmaceutics. This course will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines.
- Facility Design
- Regulatory Affairs
- Validation
- Good Manufacturing Practice (GMP)
Course learning outcomes
- Identify the key events in the evolution of current regulation of pharmaceutical manufacturing
- Explain the role of the regulatory authorities (TGA, FDA, EMA, etc) in ensuring pharmaceutical product safety and efficacy
- Design a strategy to implement validation to pharmaceutical manufacturing and analytical techniques
- Design a strategy to implement Good Manufacturing Practice to pharmaceutical manufacturing
- Identify cleaning agents and describe the principles behind CIP and SIP to pharmaceutical manufacturing
- Design the layout of a pharmaceutical manufacturing facility
- Locate sources for regulatory guidance
- Write a report in a professional style
Availability
Class details
Adelaide City Campus East
Class number 56927
Section WS01
Size 40
Available 40
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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.