Master of Science (Good Manufacturing Practices and Quality Management)
Overview
This program covers the code of conduct referred to as the 'code of Good Manufacturing Practice' (cGMP) which is crucial in the development and manufacturing of new products for the pharmaceutical, biotechnology, veterinary, medical and related industries. It also covers Quality Management (QM) within the same industries and its role as an overseer of cGMP. It is designed to be at an advanced level and will introduce students to both theory and research aspects of science (cGMP and QM).
Information sessions
Visit our Meet Us page to see when we are visiting your home country (or here in Australia).
Visit our Meet Us page to see when we are visiting your home country (or here in Australia).
| Duration | 2 Year/s | ||
Campus and intakes  |
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| Course code | Z0855 | ||
| CRICOS code | 073314M | ||
| Fees* | A$24,950 (annual for 2013)* |
*The indicative course fees shown in Course Search apply to international students studying on-campus in Australia for the relevant year only. They are based on a standard study load per year. However, please note that fees are assessed according to a student's study load in each semester, and variation to study load will result in an adjustment to tuition fees. All fees are subject to annual review and may be adjusted.
Course in detail
Course description
The Master of Science (Good Manufacturing Practices and Quality Management) is part of a nested suite of programs incorporating the
Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices)
Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices)
From Semester 1 2011, this program replaces the Master of Science (Good Manufacturing Practices) (Honours). In 2011, re-enrolling students may choose to remain enrolled in Z0854 Master of Science (Honours) (Good Manufacturing Practices) program or apply to transfer to Z0855 Master of Science (Good Manufacturing Practices and Quality Management).
(International students are required to study full-time.)
Course structure
The Master of Science (GMP & QM) program is one of a nested suite of postgraduate programs in Good Manufacturing Practices. Flexible and block mode delivery may alter time frames but not credit point requirements. Master students must undertake studies totalling 200 credit points, including a compulsory thesis, over two years (full-time) or four years (part-time).
International students must undertake the program on a full-time basis. While some units of study are available at interstate venues, international students may only undertake the program at the Hawthorn campus.
Interstate (non-Hawthorn campus) domestic applicants should note that some units of study may not be offered in some capital cities and that progression to the graduate diploma or master level of the good manufacturing suite of programs is unlikely due to the unavailability of some units of study at non-Hawthorn campus venues.
For the Master of Science (Good Manufacturing Practices and Quality Management), students must complete a total of 200 credit points as follows:
- 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) **
Notes:
** 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.
** 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.
Students undertaking HES6421 must also undertake HES6422 in the subsequent semester.
Electives must be approved prior to enrolment by the program manager or nominee to ensure a sensible theme, in which quality management is developed, has been developed within the electives.
Staff from Seer Pharma Pty Ltd teach units in this program.
(International students are required to study full-time.)
Units of study
Units of Study: (all units are valued at 12.5 credit points (cp) unless indicated otherwise)
Group A (Core) HES6401 International Good Manufacturing Practices and Quality Assurance
HES6402 Good Manufacturing Practices for Manufacturing Operations
HES6403 Validation Principles
HES6404 Good Quality Control Laboratory Practices
HES6405 Contamination Control
HES6402 Good Manufacturing Practices for Manufacturing Operations
HES6403 Validation Principles
HES6404 Good Quality Control Laboratory Practices
HES6405 Contamination Control
Group B (Process Development Units)
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
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
Group C (Electives)
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 *
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 *
Group D (Electives)
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6427 Chemometrics
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6516 Environmental Management *
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6427 Chemometrics
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6516 Environmental Management *
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
Group E (Project Units)
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)
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)
* Only available at Hawthorn campus
Notes:
Students undertaking HES6421 must also undertake HES6422 in the subsequent semester.
Students undertaking HES6421 must also undertake HES6422 in the subsequent semester.
Elective units of study may be added or removed from time to time as determined by the program manager and Faculty of Life and Social Sciences Academic Committee.
Unit of study availability may vary due to enrolment quotas, timetable constraints, location and staff availability.
Graduate outcomes
Aims and objectives
The program aims to:
- 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.
The specific objective of this master degree is to provide students with an advanced understanding of good manufacturing practices and to provide an avenue for students of exceptional ability and interest to develop both breadth and depth of theoretical and practical understanding of the topic.
Entry requirements
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.
Prerequisites
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).
Apply
Course fees*
A$24,950 (annual for 2013)*The indicative course fees shown in Course Search apply to international students studying on-campus in Australia for the relevant year only. They are based on a standard study load per year. However, please note that fees are assessed according to a student's study load in each semester, and variation to study load will result in an adjustment to tuition fees. All fees are subject to annual review and may be adjusted.
Scholarships
A range of scholarships is available to international students, visit our Scholarship Page for details.Find out more
Enquire online: http://www.swinburne.edu.au/international/enquiry
Email: international@swinburne.edu.au
Phone:
+613 8676 7002 (outside Australia)
Freecall 1800 897 973 (within Australia)
Phone:
+613 8676 7002 (outside Australia)
Freecall 1800 897 973 (within Australia)
