96067 Supply Chain Management
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Subject handbook information prior to 2024 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Description
This subject provides an overview of the complex supply chains involved in the manufacture of pharmaceuticals. It describes the challenges faced by the industry and regulatory bodies, and the current initiatives to minimise the risks and improve regulatory oversight.
Students are provided with detailed information relating to the control of materials and components by the original manufacturer and throughout the supply chain; as well as to the chain of systems ensuring the integrity and accuracy of information from originator to routine production and on to the customer. The roles and responsibilities of pharmaceutical manufacturers and their suppliers are explored, and the importance of collaboration in the supply chain to identify and manage risks, ensuring the safety and reliable supply of effective medicines. A model for supplier qualification is presented, and students are supported in the design and development of a robust and comprehensive quality system that addresses the requirements for traceability and interoperability throughout the supply chain.
Subject learning objectives (SLOs)
| 044. | Recognise the importance of supply chain management in organisations and the role it plays in ultimately ensuring product quality |
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| 045. | Explain the purpose of regulations and quality management systems supporting the supply chain |
| 046. | Evaluate risks to the supply chain and propose a course of action for supply chain decisions |
| 047. | Identify and evaluate emerging regulatory and industry initiatives to address supply chain integrity |
| 048. | Develop strategies for selecting and managing vendors by using a range of risk and qualification tools and techniques |
| 049. | Demonstrate an understanding of the requirements for Good Wholesaling and Distribution Practices |
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 accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- 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)
- Collaborate effectively with other professions to ensure Good Manufacturing Practice. (02.10)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
Contribution to the development of graduate attributes
Supply Chain Management is required before, during and after the pharmaceutical manufacturing stages and can have a strong impact on product quality and availability. This subject contributes to the Master of GMP program by providing students the opportunity to understand the complex nature of the supply chain and develop strategies for minimizing risks to the product and patient.
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.
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 in groups during collaborative and interactive experiences. 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.
Content (topics)
In this subject you will learn how to manage your supply chain from beginning to end, developing your skills in supply chain quality systems, risk management, outsourcing and more. The course if presented in 6 two-week modules each covering an important aspect of Supply Chain Management.
Module 1: Supply Chain Management
Understand the structure and regulation of the pharmaceutical supply chain and explore the challenges facing supply chains today. In this module we cover the regulatory environment for supply of medicines and ingredients with group workshops investigating current regulatory and industry initiatives.
Module 2: A Quality Systems Approach
Your company has a quality system, but what about your suppliers, and your suppliers’ suppliers? In this module we take an in depth look at the role of knowledge, control, continuous improvement and risk management in supply chain management and also step through a structured process for choosing a vendor who will meet your requirements for quality.
Module 3: Applying Quality Risk Management
With reference to ICH Q9 we will identify and evaluate risks in the supply chain, mitigating risks by audits, Quality Agreements, sampling and testing.
Module 4: Risk Management Strategies for Outsourcing
Outsourcing carries additional risks which will be studied as part of a comprehensive supply chain strategy. In this module we look at putting the theory from module 3 into practice in the context of outsourcing manufacturing and testing.
Module 5: Managing the Cold Chain
With increasing regulatory scrutiny of environmental conditions of products during storage and transport, you will explore the cold chain including the need for control, guidelines, technologies and qualification strategies.
Module 6: Identification and Traceability
Learn to identify the principles needed to manage and coordinate the flow of information between trading partners to ensure good are traceable throughout the supply chain in order to meet current and emerging requirements. In addition we will explore the role of third party logistics providers.
Assessment
Assessment task 1: Ongoing Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 044, 045, 046, 047 and 049 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08, 02.10 and 03.11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Provided via Canvas |
Assessment task 2: Module Reviews
| Intent: | Module reviews are held after each of the six (6) modules to give you feedback on your progress in understanding key concepts for each topic. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 044, 045, 047 and 049 This task is aligned with the following course learning outcomes: 02.01, 02.02, 02.03, 02.04, 02.06 and 03.11 |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | Approximately 200-300 words. |
| Criteria: | Provided via Canvas |
Assessment task 3: A Quality Assurance Plan for Supply
| Intent: | This assessment provides you with the opportunity elaborate on a quality systems approach to supply chain management by exploring a Quality Assurance Plan, product transport options and the regulatory framework. Preparing a report of this nature is a key skill in professional practice. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 044, 045, 046 and 048 This task is aligned with the following course learning outcomes: 02.02, 02.03, 02.05, 02.06 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | Up to 3000 words. |
| Criteria: | Provided via Canvas |
Assessment task 4: Vendor Selection and Management Report
| Intent: | As supply chains get more complicated, government and industry have put a stronger emphasis on safety and quality of pharmaceuticals. Implementing the right supply chain strategy has therefore become much more critical and complex. This assessment task helps students to apply their understanding of selecting and monitoring key suppliers in the supply chain. Preparing a report describing a system for supplier selection and including risk assessment is an authentic exercise that replicates likely activities in the workplace. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 044, 046 and 048 This task is aligned with the following course learning outcomes: 02.01, 02.02, 02.03, 02.05, 02.06 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | Up to 3000 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.
Required texts
Provided via the subject Canvas site
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)