C04301v2 Master of Good Manufacturing Practice
Award(s): Master of Good Manufacturing Practice (MGMP)CRICOS code: 084264C
Commonwealth supported place?: No
Load credit points: 96
Course EFTSL: 2
Location: City campus
Overview
Career options
Course intended learning outcomes
Admission requirements
Course duration and attendance
Course structure
Course completion requirements
Course program
Other information
Overview
The Master of Good Manufacturing Practice provides up-to-date and in-depth good manufacturing practice (GMP) knowledge within the pharmaceutical, biotechnology and medical device industries. The course provides critical knowledge of legislation relating to the registration, manufacture, storage and supply of licenced therapeutic goods; GxP and quality systems compliance; and the concepts of quality management, risk management, quality assurance and quality control within this heavily regulated industry – all essential ingredients for career development.
This is the only course of its kind in the Asia–Pacific region. The UTS: Pharmacy discipline has partnered with SeerPharma, the industry’s leading provider of technical compliance and quality assurance knowledge, to deliver students a practice-based and research-led education.
Designed by leading experts in the field, the course provides professional development options and career pathways for students at all levels of industry organisations. It is ideal for students wishing to commence or enhance their pharmaceutical industry manufacturing career with an industry-recognised qualification.
Career options
Career options include:
- production, quality assurance, quality control, documentation, validation, supply chain and regulatory compliance in the pharmaceutical, biotechnology and medical device industry
- monitoring and quality assurance in clinical research organisations
- auditing in government regulatory agencies, consultancy in consulting firms and managers and practitioners in various other associated companies where good manufacturing practices are required.
Course intended learning outcomes
| 01.09 | Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. |
| 02.01 | Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. |
| 02.02 | Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. |
| 02.03 | Design, implement and evaluate control systems for pharmaceuticals manufacturing. |
| 02.04 | Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. |
| 02.05 | Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. |
| 02.06 | Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. |
| 02.08 | Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. |
| 02.10 | Collaborate effectively with other professions to ensure Good Manufacturing Practice. |
| 03.11 | Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. |
| 04.07 | Demonstrate respect and value for diverse ways of knowing, being and doing, in particular recognising the diversity of Indigenous Australians, while critically reflecting on the impact of ongoing colonisation and its pervasive discourse on their health and wellbeing, and integrating this knowledge into practice |
Admission requirements
Applicants must have completed a UTS recognised bachelor's degree, or an equivalent or higher qualification, or submitted other evidence of general and professional qualifications that demonstrates potential to pursue graduate studies.
The above qualifications must be in one of the following related disciplines:
- pharmacy and pharmaceutical sciences
- chemistry
- biotechnology and bioinformatics
- microbiology
- food technology, cosmetics, and nutraceutical
- science or medical science
- engineering and related technologies.
Applicants who do not satisfy the above academic and additional requirements may be considered on the basis of general and professional qualifications that demonstrate potential to pursue graduate studies via submission of a CV.
The English proficiency requirement for international students or local applicants with international qualifications is: Academic IELTS: 6.5 overall with a writing score of 6.0; or TOEFL: paper based: 550-583 overall with TWE of 4.5, internet based: 79-93 overall with a writing score of 21; or AE5: Pass; or PTE: 58-64; or CAE: 176-184.
Eligibility for admission does not guarantee offer of a place.
International students
Visa requirement: To obtain a student visa to study in Australia, international students must enrol full time and on campus. Australian student visa regulations also require international students studying on student visas to complete the course within the standard full-time duration. Students can extend their courses only in exceptional circumstances.
Local students
Domestic applicants can apply directly or via the Universities Admissions Centre (UAC).
International students
International applicants apply via UTS: International.
International applicants, in addition to the above requirements, are required to obtain a police certificate/criminal clearance from every country they have resided in. If a country does not issue police certificates/criminal clearances, applicants are required to complete a Statutory Declaration for Overseas Students.
Course duration and attendance
This course is offered on a two-year, full-time or four-year, part-time basis.
Students can undertake this course on campus or by distance (online).
International students may not be eligible for an Australian student visa if subjects are undertaken by distance (online).
Course structure
Students must complete 96 credit points of study, including 84 credit points of coursework and 12 credit points of research.
Course completion requirements
| STM91014 Core subjects (Manufacturing Practice) | 96cp | |
| Total | 96cp |
Course program
Typical full-time and part-time course programs for Autumn B and Spring B commencements as well as on campus and distance (online) enrolment are provided below. These show a suggested study sequence. The subjects are offered in either Autumn B or Spring B sessions. Each student's course program depends on the sequence of undertaken subjects.
| On campus, Autumn B commencing, full time | ||
| Year 1 | ||
| Autumn B Session | ||
| 96057 GMP for Manufacturing Operations | 6cp | |
| 96134 Validation Principles and Practices | 6cp | |
| 96059 International GMPs and Quality Assurance | 6cp | |
| 96060 Good (Quality Control) Laboratory Practices | 6cp | |
| Spring B Session | ||
| 96069 Contamination Control | 6cp | |
| 96062 Good Aseptic Practices and Sterile Products | 6cp | |
| 96063 GxP and Quality Auditing Practices | 6cp | |
| 96064 Risk Management for Pharmaceutical Operations | 6cp | |
| Year 2 | ||
| Autumn B Session | ||
| 96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms | 6cp | |
| 96066 Clinical Trials Quality Assurance Management | 6cp | |
| 96067 Supply Chain Management | 6cp | |
| 96068 Industrial Research Project A | 6cp | |
| Spring B Session | ||
| 96061 Computer Systems Validation Principles and Practices | 6cp | |
| 96098 Stability | 6cp | |
| 96135 Biotech Manufacturing | 6cp | |
| 96072 Industrial Research Project B | 6cp | |
| Spring B commencing, full time | ||
| Year 1 | ||
| Spring B Session | ||
| 96069 Contamination Control | 6cp | |
| 96062 Good Aseptic Practices and Sterile Products | 6cp | |
| 96063 GxP and Quality Auditing Practices | 6cp | |
| 96064 Risk Management for Pharmaceutical Operations | 6cp | |
| Year 2 | ||
| Autumn B Session | ||
| 96057 GMP for Manufacturing Operations | 6cp | |
| 96134 Validation Principles and Practices | 6cp | |
| 96059 International GMPs and Quality Assurance | 6cp | |
| 96060 Good (Quality Control) Laboratory Practices | 6cp | |
| Spring B Session | ||
| 96061 Computer Systems Validation Principles and Practices | 6cp | |
| 96098 Stability | 6cp | |
| 96135 Biotech Manufacturing | 6cp | |
| 96072 Industrial Research Project B | 6cp | |
| Year 3 | ||
| Autumn B Session | ||
| 96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms | 6cp | |
| 96066 Clinical Trials Quality Assurance Management | 6cp | |
| 96067 Supply Chain Management | 6cp | |
| 96068 Industrial Research Project A | 6cp | |
| Distance, Autumn B commencing, part time | ||
| Year 1 | ||
| Autumn B Session | ||
| 96059 International GMPs and Quality Assurance | 6cp | |
| 96057 GMP for Manufacturing Operations | 6cp | |
| Spring B Session | ||
| 96064 Risk Management for Pharmaceutical Operations | 6cp | |
| 96063 GxP and Quality Auditing Practices | 6cp | |
| Year 2 | ||
| Autumn B Session | ||
| 96060 Good (Quality Control) Laboratory Practices | 6cp | |
| 96134 Validation Principles and Practices | 6cp | |
| Spring B Session | ||
| 96069 Contamination Control | 6cp | |
| 96062 Good Aseptic Practices and Sterile Products | 6cp | |
| Year 3 | ||
| Autumn B Session | ||
| 96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms | 6cp | |
| 96066 Clinical Trials Quality Assurance Management | 6cp | |
| Spring B Session | ||
| 96061 Computer Systems Validation Principles and Practices | 6cp | |
| 96098 Stability | 6cp | |
| Year 4 | ||
| Autumn B Session | ||
| 96067 Supply Chain Management | 6cp | |
| 96068 Industrial Research Project A | 6cp | |
| Spring B Session | ||
| 96135 Biotech Manufacturing | 6cp | |
| 96072 Industrial Research Project B | 6cp | |
| Distance, Spring B commencing, part time | ||
| Year 1 | ||
| Spring B Session | ||
| 96064 Risk Management for Pharmaceutical Operations | 6cp | |
| 96063 GxP and Quality Auditing Practices | 6cp | |
| Year 2 | ||
| Autumn B Session | ||
| 96059 International GMPs and Quality Assurance | 6cp | |
| 96057 GMP for Manufacturing Operations | 6cp | |
| Spring B Session | ||
| 96069 Contamination Control | 6cp | |
| 96062 Good Aseptic Practices and Sterile Products | 6cp | |
| Year 3 | ||
| Autumn B Session | ||
| 96060 Good (Quality Control) Laboratory Practices | 6cp | |
| 96134 Validation Principles and Practices | 6cp | |
| Spring B Session | ||
| 96061 Computer Systems Validation Principles and Practices | 6cp | |
| 96098 Stability | 6cp | |
| Year 4 | ||
| Autumn B Session | ||
| 96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms | 6cp | |
| 96066 Clinical Trials Quality Assurance Management | 6cp | |
| Spring B Session | ||
| 96135 Biotech Manufacturing | 6cp | |
| 96072 Industrial Research Project B | 6cp | |
| Year 5 | ||
| Autumn B Session | ||
| 96067 Supply Chain Management | 6cp | |
| 96068 Industrial Research Project A | 6cp | |
Other information
Register to attend an information session and/or contact:
Graduate School of Health
telephone +61 2 9514 1448
email gsh.future@uts.edu.au