96057 GMP for Manufacturing Operations
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Subject handbook information prior to 2025 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
There are course requisites for this subject. See access conditions.
Description
This is a foundation subject in the Master of Good Manufacturing Practice (C04301) (GMP). This subject provides an overview of manufacturing and packaging operations, risk management, risk assessment and their application in improving decision making processes and optimising good manufacturing practice (GMP) compliance. The subject explores the roles and responsibilities of managers and supervisors in a pharmaceutical manufacturing environment. The contribution of systematic competency-based training is examined.
Subject learning objectives (SLOs)
| 001. | Assess the design and effectiveness of GMP documentation against regulatory standards and guidelines |
|---|---|
| 002. | Explain and apply GMP and Quality Assurance requirements to specific manufacturing and packaging operations |
| 003. | Develop an action plan and/or a recommendations report and be able to defend and justify your decisions to colleagues and/or managers |
| 004. | Explain the principles and major concepts in risk assessment |
| 005. | Apply statistical process control techniques to manufacturing processes |
| 006. | Examine the ways in which personnel can influence and improve GMP behaviours |
| 007. | Generate ideas and contributions within a group dynamic, demonstrating effective communication and collaboration |
Contribution to the development of graduate attributes
Here students become familiar with the skills and knowledge necessary to apply GMP principles to ensure quality manufacturing, packaging and management of pharmaceutical operations.
This subject contributes towards developing the following Graduate Attributes:
Lifelong learning
Graduates of the Master of Good Manufacturing Practice 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 Good Manufacturing Practice are quality-focussed, ethical professionals with the understanding and proficiency to be leaders in their profession, capable of effectively researching and communicating solutions in a global context.
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.
Teaching and learning strategies
On campus (standard) mode: This subject will be 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 personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
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 together during collaborative and interactive experiences. Students will need to develop negotiation and teamwork skills, demonstrating 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.
Content (topics)
This subject gives students an insight into practical factory application of GMP, from manufacture and packaging of pharmaceutical products, to APIs.
Module 1: Manufacturing
How to ensure that pharmaceutical manufacturing is carried out in appropriately designed, qualified and maintained
facilities including materials and manufacturing controls.
Module 2: Packaging and Labelling
Applying GMP to packaging and labelling operations including printed material control, sampling and reconciliation
Module 3: Personnel
Explore the concepts and practical aspects of a supervisor’s role in influencing GMP compliance through leadership,
training and problem-solving.
Module 4: Risk Management
Explore key concepts of risk in ICH guidance and how risk management practices support compliance programs
Module 5: Statistical Process Control
Implement and interpret the application of statistics to manufacturing process controls
Module 6: Applications
Build on the foundations from modules 1-5, applying them to the manufacture of Active Pharmaceutical Ingredients (APIs). Then further expand these foundations by organising pharmaceutical facility visit or inviting industry speaker to help consolidate and reinforce the concepts and practice of GMP in pharmaceutical manufacturing.
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 discussions and receive ongoing formative feedback from their peers and teacher. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 001, 002, 003, 004, 005, 006 and 007 This task is aligned with the following course learning outcomes: .01, .04, .06, .08 and .11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | 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: Report (GMP Deficiencies, Part A)
| Intent: | The ability to investigate and address GMP deficiencies at a technical level, and defend your work is a foundational skill required for industry practice. This assessment provides you the opportunity to demonstrate your understanding of how to deal with GMP issues and practice your communication skills in an industrial scenario based setting. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 001, 002 and 003 This task is aligned with the following course learning outcomes: .04, .06, .08 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | Part A Report: 1000 words |
| Criteria: | Please refer to Canvas for assessment criteria. |
Assessment task 3: Report (GMP Deficiencies, Part B)
| Intent: | The ability to investigate and address GMP deficiencies at a technical level, and defend your work is a foundational skill required for industry practice. This assessment provides you the opportunity to demonstrate your understanding of how to deal with GMP issues and practice your communication skills in an industrial scenario-based setting. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 001, 002, 004, 005 and 006 This task is aligned with the following course learning outcomes: .01, .04, .06, .08 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 35% |
| Length: | Part B Report: 1500 words |
| Criteria: | Please refer to Canvas for assessment criteria. |
Assessment task 4: Video
| Intent: | This provides you the opportunity to demonstrate how you would influence the GMP behaviours of manufacturing operators via an educational video. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 006 and 007 This task is aligned with the following course learning outcomes: .04, .08 and .11 |
| Type: | Presentation |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 3-5 minutes |
| Criteria: | Available on 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.
Required texts
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Please refer to the Subject Canvas site
Recommended texts
The PIC/S Code of GMP, which you will use, must be kept for all subjects.
- PE 009-13 (Part I) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part I)*
- PE 009-13 (Part II) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part II)*
- PE 009-13 (Annexes) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Annexes)*
Other relevant references are:
ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices
21 CFR Part 211 Good Manufacturing Practice for Finished Pharmaceuticals*
FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations *
FDA Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance *
FDA Compliance Program Guidance Manual Program 7356.002 Drug Manufacturing Inspections*
ICH Q9: Quality Risk Management*
WHO Quality assurance of pharmaceuticals Volume 2, Good manufacturing practices and inspection *
WHO Guidelines for Sampling of Pharmaceutical and Related Materials *
Items marked with ‘*’ are available online at no charge