University of Technology Sydney

96059 International GMPs and Quality Assurance

Warning: The information on this page is indicative. The subject outline for a particular session, location and mode of offering is the authoritative source of all information about the subject for that offering. Required texts, recommended texts and references in particular are likely to change. Students will be provided with a subject outline once they enrol in the subject.

Subject handbook information prior to 2022 is available in the Archives.

UTS: Health (GEM)
Credit points: 6 cp
Result type: Grade and marks

There are course requisites for this subject. See access conditions.

Description

This subject provides an introduction to good manufacturing practice (GMP), with a focus on international aspects and quality assurance (QA). It covers the fundamental requirements for GMPs and the obligations of manufacturers and managers to implement or maintain GMP compliance and QA in the manufacture of human or veterinary therapeutic products. It reviews critical QA systems including design and change control, deviation and error control, and corrective and preventative action (CAPA). Documentation systems and practices related to GMP are also addressed. GMP requirements for manuals, policies, standard operating procedures (SOPs), work instructions and records are explored, leading to discussion on a model hierarchical documentation system based on ISO 9000, a body of quality management systems standards. This subject investigates change control programs and overviews the cGMP requirements for managing complaints and recalls.

Subject learning objectives (SLOs)

015. Assess levels of GMP compliance against recognised standards and provide advice on regulatory requirements and best practices.
016. Review and report on the compliance requirements for registering and listing medicines in Australia.
017. Review the historical development of GMP in Australia, Europe and the USA, and compare the approaches and the compliance and enforcement tools used by each regulatory agency.
018. Analyse and report on the approaches and requirements of the ICH Guidance on Pharmaceutical Quality Systems.
019. Design and author clear operating procedures for manufacturing and quality processes, with reference to current GMP requirements and appropriate writing standards.
020. Assess impacts of changes to products and processes, and provide advice on regulatory requirements.
021. Assess impacts of customer complaints and provide advice on regulatory requirements.
022. Evaluate own learning needs and direct own learning experiences.
023. Provide constructive feedback to peers.

Course intended learning outcomes (CILOs)

The learning outcomes for this subject are as follows:

  • 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. (01.09)
  • Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
  • Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
  • Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
  • Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
  • 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 (04.07)

Contribution to the development of graduate attributes

QA has a significant role in industry and in GMP. This subject contributes to the Master of GMP program by providing students the opportunity to develop practical strategies which can then be applied in the workforce. Scenario based case studies provide a platform for students to prepare a Quality plan and worksite audits for GMP compliance. This facilitates a deeper understanding of current requirements and future international trends within industry.

This subject contributes towards developing the following Graduate Attributes:

Lifelong learning:

Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.

Professional capacity:

Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.

Global citizenship

Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.

Cultural competence

Graduates of the Master of Good Manufacturing Practice are culturally competent professionals, able to reflect on and explain their own cultural perspectives, accommodate cultural differences and achieve optimal outcomes through the adoption of a consultative approach to health care with indigenous Australians and other cultural groups.

Teaching and learning strategies

On-campus (standard) mode: This subject is normally delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of pre-work before each workshop. However, due to the COVID-19 emergency, until advised, contact meetings for this subject will be conducted online only. There will be no face-to-face or on-campus classes for this subject. Online meetings via video conferencing will be conducted each week comprising small group workshops to learn the application of class materials. The format and content of these classes will be equivalent to face to face on-campus classes. Students are expected to complete personal study via the Canvas platform each week as preparation for class. It is expected that all students participate in the set activities during the scheduled time-slot for class. Attendance rolls will be marked.

Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week.

Students will learn in this Subject through online content comprising videos, set reading, directed research, activities online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined

Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.

Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.

  • On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.
  • Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.

Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.

  • On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.
  • Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.

Strategy 4: Group work: students work in groups during collaborative and interactive experiences as well as an assessment. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and respect for diverse ways of working.

Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.

OPELA (online language screening task)

An aim of this subject is to help you develop academic and professional language and communication skills in order to succeed at university and in the workplace. To determine your current academic language proficiency, you are required to complete an online language screening task, OPELA (information available at https://www.uts.edu.au/research-and-teaching/learning-and-teaching/enhancing/language-and-learning/about-opela-students). If you receive a Basic grade for OPELA, you must attend follow up language development activities in order to pass the subject. These activities are outlined below:

On campus students: You must attend additional Language Development Tutorials (each week from week [3/4] to week [11/12]. These tutorials are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not attend 80% of the Language Development Tutorials will receive a Fail X grade.

Online students: You must complete additional language development activities during the teaching session. The activities will be made available to you online during the teaching session. These activities are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not complete 80% of the language activities will receive a Fail X grade.

Content (topics)

This subject is a keystone to the course as it introduces students to the scope of international GMPs and Quality Management Systems. Students focus on how key business processes are implemented within a pharmaceutical manufacturing company that facilitate both operational effectiveness and GMP compliance.

Module 1: The Regulatory Environment

Understand GMP’s place in the world with exploration of the historical evolution of GMP and current requirements in Australia, Europe and USA.

Module 2: Quality Management

Delve into the relationship between Quality Management Systems, Quality Assurance, GMP and Quality Control in pharmaceutical manufacturing, exploring various quality system models such as ICH Q10 and FDA’s model. This module also includes a risk based approach to GMP, Release for Supply requirements and GMP requirements for Outsourcing.

Module 3: Documentation Management

You may have heard the saying ‘If it isn’t written down, it didn’t happen’. In this module we look at the critical role documentation plays in a GMP environment and how to prepare and analyse GMP documents.

Module 4: Continuous Improvement in Pharmaceutical Quality Systems
Now that you have an understanding of quality system models, you will learn aout the practical implementation of GMP quality systems by applying Risk Management principles to common elements including audit, deviation, Corrective and Preventive Actions and Failure Investigation.

Module 5: Change Management
Change management is one of the most difficult but most important QA systems to implement in a company so students focus on the definition of change control, the differences between change control and document change control, levels of change and responsibilities as well as regulatory requirements and guidance.

Module 6: Post-Market Monitoring
Finally, GMP and QA responsibilities continue after product leaves the warehouse so students learn about post-market monitoring and pharmacovigilance requirements that relate to defects/complaints identified in the marketplace.

Indigenous Medicinals - On Campus Students

In addition, this subject includes a module studying Indigenous Medicinals. In groups, students visit Waraburranura, the UTS indigenous garden, and investigate the medicinal properties of a chosen plant from the garden. In a collaborative workshop with 96002: Concepts in Pharmaceutical Sciences, students hear the fascinating history and use of medicinal plants from D'harawal elder, Aunty Fran Bodkin, and share their research with the group.

Indigenous Medicinals - Online Students

In addition, this subject includes a module studying Indigenous Medicinals in which students are exposed to plants traditionally used as medicine and share their research with the group.

Assessment

Assessment task 1: On-going Graded Assessment

Intent:

This assessment task provides students with the opportunity to test their understanding of the course content through online discussion and receive ongoing formative feedback from their peers and teacher.

Objective(s):

This task is aligned with the following subject learning objectives:

015, 016, 017, 018, 019, 020, 021, 022 and 023

This task is aligned with the following course learning outcomes:

01.09, 02.04, 02.06, 02.08, 03.11 and 04.07

Groupwork: Individual
Weight: 15%
Criteria:

On campus students: Tasks are marked online or by the teacher according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles taught. A rubric for assessment of participation in on-line discussions will be provided on Canvas.

Online students: Posts will be assessed against four criteria: Including and applying relevant course concepts; Responding to fellow learners; Applying relevant professional, personal or other real-world experiences; Supporting position with applicable resources. A rubric for assessment of online discussions is available in Canvas.

Assessment task 2: Regulatory Agency Report

Intent:

One of the major challenges for the industry is navigating the different regulations, standards and guidances available from different authorities and making decisions on what is “best-practice” and what is right for the organisation. This assessment allows you to explore these challenges and learn about the major differences and minor nuances that must be understood and followed for GMP compliance.

Objective(s):

This task is aligned with the following subject learning objectives:

015, 016 and 017

This task is aligned with the following course learning outcomes:

02.06 and 03.11

Type: Report
Groupwork: Individual
Weight: 15%
Length:

750-1250 words

Criteria:

Provided via Canvas

Assessment task 3: Quality Systems Assignment

Intent:

Collaborating with your peers, this assignment provides you with the opportunity to demonstrate your ability to work in a group to interpret the requirements of a regulatory guideline and to design, write and implement an ICH Q10-compliant quality system element in an organisation; giving you experience in the challenges routinely faced in industry.

SOPs are the main building blocks of a Pharmaceutical Quality System (PQS) and, by their nature and objective, connect to all other building blocks of the PQS. SOPs are meant to harmonize operational practices, reduce user errors; they can be used as training tools. Moreover, they help ensure compliance to regulations and international standards.

Objective(s):

This task is aligned with the following subject learning objectives:

015, 018, 019 and 023

This task is aligned with the following course learning outcomes:

02.04, 02.06, 02.08 and 03.11

Type: Project
Groupwork: Group, individually assessed
Weight: 35%
Length:

Stage 1 - Presentation max 7 slides; 7 minutes

Stage 2 - 1500 words

Criteria:

Provided via Canvas

Assessment task 4: Continuous Improvement Plan

Intent:

Continuous Improvement is fundamental to Good Manufacturing Practice. In the assessment you will apply the principles of continuous improvement to a industry based complaint management scenario and propose an appropriate change plan.

Objective(s):

This task is aligned with the following subject learning objectives:

015, 020 and 021

This task is aligned with the following course learning outcomes:

01.09, 02.04, 02.06, 02.08 and 03.11

Type: Project
Groupwork: Individual
Weight: 35%
Length:

Approx 1500 words

Criteria:

Provided via Canvas

Minimum requirements

On Campus Mode

In order to pass this Subject, a minimum grade of 50% must be achieved.

Students are required to attend a minimum of 85% of classes, and submit all assessment tasks

Online Mode

In order to pass this Subject, a minimum grade of 50% must be achieved and students must submit all assessment tasks.

OPELA

It is a requirement of this subject that all students complete OPELA. Students who received a Basic grade in the OPELA are required to attend 80% of the Language Development Tutorials, or, for online students, complete 80% of compulsory language activities in order to pass the subject. Students who do not complete the OPELA and/or do not complete 80% of the Language Development Tutorials or compulsory language activities will receive a Fail X grade.

Required texts

Provided via the subject Canvas site

Coursework Assessments Policy

Coursework Assessments Procedures

Graduate School of Health Policy, Guidelines and Procedures (login required)

Recommended texts

The following material will aid in the student’s understanding of this subject. Students are expected to have read them. Additional reference material will be provided by the lecturer(s) throughout the session which will be available on Canvas.

FDA Codes of GMP: 21CFR Part 211*

PIC/S Guide to GMP*

FDA Guidance for Industry Quality Systems Approach to Pharmaceutical cGMP Regulations Sept 2006*

FDA Guide to Inspections of Quality Systems*

FDA Compliance Program Guidance Manual Program 7356.002 Drug Manufacturing Inspections*

ICH Q8: Pharmaceutical Development November 2006*

ICH Q9: Quality Risk Management November 2006*

ICH Q10: Pharmaceutical Quality Systems 2008*

WHO Quality assurance of pharmaceuticals A compendium of guidelines and related materials Volume 2, 2nd updated edition*

Note: Documents marked with an asterisk are available free of charge from the internet.