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, skills, and experience within the pharmaceutical, biotechnology, and medical device industries. The course provides students with critical knowledge and the ability to evaluate and apply legislation relating to the registration, manufacture, storage, and supply of licensed therapeutic goods; GxP and quality systems compliance; and the concepts of quality management, risk management, aseptic practices, supply chain, clinical trials, quality assurance, and quality control within this heavily regulated industry – all essential ingredients for career development.
The UTS: Pharmacy Discipline offers the only post-graduate qualification in GMP in the Asia-Pacific region and partners with SeerPharma, the industry’s leading provider of technical compliance and quality assurance knowledge, to deliver a practice-based and research-led education to students.
Designed by leading experts in the field, the course provides students with professional development options and career pathways at all levels of industry organisations. It is ideal for students who would like to commence or enhance their pharmaceutical industry manufacturing career with an industry-recognised qualification.
Career options
Career options include:
- Production Manager/ Supervisor, Quality Assurance Manager/ Associate, Industrial Pharmacist, Quality Control Manager, Documentation Manager, Validation Manager, Supply Chain Manager, and Regulatory Affairs Manager/Associate in the pharmaceutical, biotechnology, medical device, and allied industries.
- Auditor in government regulatory agencies, consultant in consulting firms, and managers and practitioners in various other associated companies where good manufacturing practices are required.
Course intended learning outcomes
| 01.01 | Reflect on the knowledge, skills and attributes required for the evaluation of current regulatory documents in Good Manufacturing Practice promoting the growth of personal and professional learning. |
| 02.01 | Devise, evaluate, audit, and validate practices and processes using appropriate methodologies in a wide range of local, national and global Good Manufacturing Practice contexts. |
| 02.02 | Interpret published standards and requirements to design ethically and legally accountable approaches to pharmaceutical manufacturing and control. |
| 02.03 | Devise and implement quality-focussed research and evidence-based, ethical and legally accountable solutions and/or approaches across a wide range of Good Manufacturing Practice fields. |
| 02.04 | Communicate effectively as an individual or within a team with colleagues, clients and stakeholders in written or spoken language appropriate to their needs. |
| 04.01 | Critically reflect on Indigenous Australian contexts to inform professional capability to work effectively with and for Indigenous Australians across Good Manufacturing Practice. |
Admission requirements
To be eligible for admission to this course, applicants must meet the following criteria.
Applicants must have one of the following:
- Completed Australian bachelor's degree or higher qualification, or overseas equivalent, in a related field of study with a minimum GPA of 5/7
OR
- Completed Australian bachelor's degree or higher qualification, or overseas equivalent, in a related field of study with a GPA below 5/7 AND A minimum of 2 years full-time, or equivalent part-time, relevant professional experience AND Communication skills, interpersonal skills, an interest in an industry where good manufacturing practices are involved, and a commitment to good manufacturing practice as a career (assessed through an interview)
Applicants who do not meet the criteria above should consider applying for C11249 Graduate Certificate in Good Manufacturing Practice.
Supporting documentation to be submitted with the application
For applicants required to demonstrate work experience:
- Curriculum Vitae AND Statement of Service in one of the following formats:
- A 'Statement of Service' provided by the employer
- A completed 'UTS statement of service’ signed by the employer
- A statutory declaration confirming work experience (for Australian Residents only)
- An official letter from the applicant’s accountant or solicitor on their company letterhead confirming the applicant’s work experience or engagement with the business, duration of operations, and the nature of the business
- A business certificate of registration in original language and English (e.g. provision of ASIC documentation or ABN or similar documentation for Australian Businesses)
Related fields of study include:
Pharmacy and Pharmaceutical Sciences, Chemistry, Biotechnology and Bioinformatics, Microbiology, Food Technology, Cosmetics, and Nutraceutical, Science or Medical science, Engineering and related technologies
The English proficiency requirement for international students or local applicants with international qualifications is: IELTS Academic: 6.5 overall with a writing score of 6.0; or TOEFL iBT: 79-93 overall with a writing score of 21; or AE5: Pass; or PTE: 58-64 with a writing score of 50; or C1A/C2P: 176-184 with a writing score of 169.
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.
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 (Good 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.
| Autumn B, 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 | |
| 96831 Medical Devices: Regulatory and Quality Systems Requirements | 6cp | |
| 96135 Biotech Manufacturing | 6cp | |
| 96072 Industrial Research Project B | 6cp | |
| Spring B, 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 | |
| 96831 Medical Devices: Regulatory and Quality Systems Requirements | 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 | |
| Autumn B, 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 | |
| 96831 Medical Devices: Regulatory and Quality Systems Requirements | 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 | |
| Spring B, 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 | |
| 96831 Medical Devices: Regulatory and Quality Systems Requirements | 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