96069 Contamination Control
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Subject handbook information prior to 2018 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 (GMP). This subject explores the principles and requirements for contamination control. It identifies the different types of contamination and potential sources of contamination, introduces risk assessment methodologies that can be used to analyse the major risks to products, and looks at how to develop strategies for contamination control. The contribution of systematic competency-based training is also explored.
Subject learning objectives (SLOs)
| 1. | Design protocols for monitoring water quality in pharmaceutical manufacturing |
|---|---|
| 2. | Evaluate a given set of contamination management systems, procedures and practices |
| 3. | Evaluate the regulatory requirements, standards and guidelines relating to contamination control in pharmaceutical manufacturing |
| 4. | Explain the principles of contamination control in pharmaceutical manufacturing |
| 5. | Analyse risk of product contamination using contamination risk evaluation techniques |
| 6. | For a given project interpret data to design an environmental monitoring program |
| 7. | Implement the most appropriate risk evaluation technique for a given set of contamination management systems, procedures and practices through the case studies |
| 8. | Using environmental monitoring data from a given project, recommend required control measures |
Contribution to the development of graduate attributes
Here students become familiar with the skills and knowledge necessary to understand the principles and requirements for contamination control.
In addition, this Subject addresses the following Course-intended Learning Outcomes
2 Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies.
3 Design, implement and evaluate control systems for pharmaceuticals manufacturing.
4 Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control.
5 Evaluate evidence and engage in systematic inquiry in order to deliver evidence-based solutions.
6 Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs.
7 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
8 Contribute as leader and collaborator in the assurance of safe manufacturing practice.
9 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.
11 Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts.
Teaching and learning strategies
This subject is delivered on the City campus on a weekly basis and requires attendance for three face-to-face contact hours per week. The formal input from the lectures is applied in weekly workshops, focusing on industry-based cases.
Content (topics)
The importance of contamination control in pharmaceutical manufacturing is explained. You will learn the physical and microbiological aspects of contamination and how these can affect the performance and safety of the pharmaceutical products. You will learn the regulations and the techniques relating to contamination control. Specific GMP areas that contamination must be controlled are addressed:
- The training of personnel
- The practice of cleaning and sanitation of equipment and facility
- The control of the environment for production and cleanrooms, and
- The design, qualification and management of pharmaceutical water systems.
Assessment
Assessment task 1: Development of a contamination control program
| Intent: | This assignment is designed to challenge you to present a practical approach to control contamination in a pharmaceutical manufacturing environment. In addition, you will present your proposed activities to ensure continued compliance of your contamination control program. |
|---|---|
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 20% |
| Length: | Approximately 1500 words |
| Criteria: | Provided via UTSOnline |
Assessment task 2: FDA case study response
| Intent: | This assignment is designed to position you in a real-life situation where there is a contamination problem in your company. This matter has been cited by the FDA. You will show your knowledge gained by proposing realistic actions to respond to the FDA citation and convince FDA that further contamination problem would be controlled. |
|---|---|
| Type: | Case study |
| Groupwork: | Individual |
| Weight: | 20% |
| Length: | Minimum of 1500 words, no limit |
| Criteria: | Provided via UTSOnline |
Assessment task 3: Mid-semester exam
| Intent: | This mid-session exam is for you to show your understanding of the control of physical, chemical and microbiological contamination. You will demonstrate these controls by the application of cleaning and sanitation methods, and the maintenance and testing of these methods. |
|---|---|
| Type: | Examination |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 1 hour and 10 mins; including 10 minutes of reading time |
Assessment task 4: Final Exam
| Intent: | This final exam is for you to show your overall understanding of the control of physical, chemical and microbiological contamination. You will demonstrate these controls through the design and implementation of HVAC systems. In addition, you will show the need for continuous environmental monitoring programs and the importance of a validated pharmaceutical grade water system. |
|---|---|
| Type: | Examination |
| Groupwork: | Individual |
| Weight: | 35% |
| Length: | 1 hour and 40 mins; including 10 minutes of reading time |
Minimum requirements
In order to pass this Subject, students are required to attend a minimum of 85% of classes, submit all assessment tasks and achieve a minimum of 50% in the final exam.
Required texts
Policy for Assessment of Coursework Subjects
Procedures for assessment of Coursework Subjects
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional required readings will be provided via UTSOnline
Recommended texts
The PIC/s Code of GMP, Annex 1
