Master of Science (Good Manufacturing Practices and Quality Management)
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|Campus and intakes|
|Fees*||A$24,950 (annual for 2013)*|
- Master of Science (Good Manufacturing Practices)
- Graduate Certificate of Science (Good Manufacturing Practices)
- Graduate Diploma of Science (Good Manufacturing Practices)
- Master of Science (Biotechnology)
- Graduate Diploma of Science (Biotechnology)
- Master of Science (Biotechnology) *Global Leadership Program
Course in detail
Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices)
- all five units of study from Group A (62.5 credit points) compulsorily including HES6401, HES6402 and HES6403
- two units of study from Group B (25 credit points)
- two units of study from Group C (25 credit points) compulsorily including HES6513
- HES6429 or HES6516 as a Group D unit of study (12.5 credit points)
- one or two units of study from Group E (25 credit points) **
- four units of study from any group (50 credit points) **
** Students who elect to undertake HES6420 Minor Thesis (50 cp) will be completing an additional 25 credit points from Group E, and will therefore only be required to complete two units of study (25 cp) from any group.
Units of study
HES6402 Good Manufacturing Practices for Manufacturing Operations
HES6403 Validation Principles
HES6404 Good Quality Control Laboratory Practices
HES6405 Contamination Control
HES6406 Process Development for Therapeutics (A) – A Perspective for Protein Therapeutics *
HES6407 Process Development for Therapeutics (B) – A Perspective for Small Molecules *
HES6408 Process Development for Therapeutics (C) – A Perspective for Medical Devices *
HES6423 Process Development for Therapeutics (D) – Perspective for Pharmaceutical Finished Dose Forms
HES6409 Validation Practices
HES6410 Good Laboratory Practices (for Non-Clinical Laboratories)
HES6411 Computer Systems Validation Principles
HES6412 Computer Systems Validation Practices
HES6413 Good Aseptic Practices and Sterile Products
HES6414 Clinical Trials Quality Assurance Management
HES6415 GxP and Quality Auditing Practices
HES6513 Research Skills *
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6516 Environmental Management *
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
HES6420 Minor Thesis (50cp)
HES6421 Minor Thesis (Part Time) A (25 cp)
HES6422 Minor Thesis (Part Time) B (25 cp)
HES6424 Minor Research Project A
HES6430 Minor Research Project B
HES6425 Major Research Project A (25 cp)
HES6431 Major Research Project B (25 cp)
Students undertaking HES6421 must also undertake HES6422 in the subsequent semester.
Aims and objectives
- educate students in the fundamental reasons behind the requirement of good manufacturing practice and quality management;
- develop in students a fundamental understanding of how good quality management and manufacturing practice operates and how the pharmaceutical, biotechnology, veterinary, medical and related industries are regulated;
- provide students with a theoretical understanding as well as practical experience in microbiological aspects of pharmaceutical manufacturing, cleaning and sanitation, documentation and record keeping, manufacturing and packaging, process control measures, supervisory responsibility, validation, quality audits, quality management, process development, clinical study requirements, regulatory body requirement, quality assurance and quality control;
- instil in students a research ethic and methodology enabling good quality scientific research.
English language requirements
Swinburne College English for Academic Purposes Certificate: EAP 5 Advanced: 70%; OR, obtaining a minimum IELTS overall band of 6.5 (Academic Module) with no individual band below 6.0; OR, a TOEFL (Paper-based) minimum score of 550 (with Test of Written English (TWE) score of 5); OR, a TOEFL (Internet-based) minimum score of 79, with no individual band below 18. Refer to the English Language Requirements website for further information.
To be eligible for the Master of Science (Good Manufacturing Practices and Quality Management), a student should normally have completed an appropriate undergraduate science degree with honours, or an appropriate four-year undergraduate engineering degree with honours. An average of 60% or higher in a four-year undergraduate degree, an honours degree in another discipline with appropriate work experience, or a first degree in science or engineering with appropriate work experience, are examples of an honours equivalence.
Students who satisfactorily meet this requirement can enrol directly into the Master program or may be allowed to articulate seamlessly from the graduate diploma (assuming successful completion) to the Master program. Students who do not satisfy this requirement may also be admitted to the Master program if they achieve a credit average or higher in the Graduate Diploma of Science (Good Manufacturing Practices).