C04301v2 Master of Good Manufacturing Practice

University of Technology Sydney

About

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.

Structure

Students must complete 96 credit points of study, including 84 credit points of coursework and 12 credit points of research.

Course completion requirements

course credit
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

course credit
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

course credit
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

course credit
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

course credit
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

course credit
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

course credit
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

course credit
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

course credit
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

course credit
96059 International GMPs and Quality Assurance 6cp
96057 GMP for Manufacturing Operations 6cp

Spring B Session

course credit
96064 Risk Management for Pharmaceutical Operations 6cp
96063 GxP and Quality Auditing Practices 6cp

Year 2

Autumn B Session

course credit
96060 Good (Quality Control) Laboratory Practices 6cp
96134 Validation Principles and Practices 6cp

Spring B Session

course credit
96069 Contamination Control 6cp
96062 Good Aseptic Practices and Sterile Products 6cp

Year 3

Autumn B Session

course credit
96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms 6cp
96066 Clinical Trials Quality Assurance Management 6cp

Spring B Session

course credit
96061 Computer Systems Validation Principles and Practices 6cp
96098 Stability 6cp

Year 4

Autumn B Session

course credit
96067 Supply Chain Management 6cp
96068 Industrial Research Project A 6cp

Spring B Session

course credit
96135 Biotech Manufacturing 6cp
96072 Industrial Research Project B 6cp

Distance, Spring B commencing, part time

Year 1

Spring B Session

course credit
96064 Risk Management for Pharmaceutical Operations 6cp
96063 GxP and Quality Auditing Practices 6cp

Year 2

Autumn B Session

course credit
96059 International GMPs and Quality Assurance 6cp
96057 GMP for Manufacturing Operations 6cp

Spring B Session

course credit
96069 Contamination Control 6cp
96062 Good Aseptic Practices and Sterile Products 6cp

Year 3

Autumn B Session

course credit
96060 Good (Quality Control) Laboratory Practices 6cp
96134 Validation Principles and Practices 6cp

Spring B Session

course credit
96061 Computer Systems Validation Principles and Practices 6cp
96098 Stability 6cp

Year 4

Autumn B Session

course credit
96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms 6cp
96066 Clinical Trials Quality Assurance Management 6cp

Spring B Session

course credit
96135 Biotech Manufacturing 6cp
96072 Industrial Research Project B 6cp

Year 5

Autumn B Session

course credit
96067 Supply Chain Management 6cp
96068 Industrial Research Project A 6cp

Entry 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.

Institution