96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms
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Subject handbook information prior to 2025 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
Solid and topical semisolids, such as tablets and creams respectively, are common dose forms produced in the pharmaceutical industry. This subject guides students through the manufacturing process of common dose forms, from required starting materials through to formulation, steps in manufacturing and final product packaging. Students develop an understanding of how full-scale manufacturing technologies function, as well as the strategic skills required for process optimisation and validation. The impact of quality assurance on finished dose forms and the importance of quality management are also studied.
Subject learning objectives (SLOs)
| 030. | Explain the manufacturing principles behind oral solid dose, oral liquid dose and topical preparations |
|---|---|
| 031. | Select and justify appropriate equipment design, process control plans and validation strategies for a given finished pharmaceutical dose form |
| 032. | Identify and maintain appropriate risk management strategies for GMP compliance for the manufacturing of a finished pharmaceutical dose form |
| 033. | Explain and justify the use and impact of various excipients used in selected finished pharmaceutical dose forms |
| 034. | Assess site production requirements and contrast the capabilities / limitations of required manufacturing equipment for the creation of finished dose forms |
| 035. | Implement appropriate quality control tests and acceptance criteria for relevant production equipment and finished dose forms |
Contribution to the development of graduate attributes
This Subject highlights the necessity for quality assurance, good manufacturing practice, good laboratory practice and quality control in the pharmaceutical industry.
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.
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)
For solid dose products you will learn the technologies and controls of the key manufacturing processes granulation, blending and milling, compression and encapsulation. You will then learn about the downstream processes of packaging and labelling. Transitioning to other finished dose forms, you will then about formulation, preparation and manufacturing of oral liquids and topical products as well as the relevant packaging operations.
Assessment
Assessment task 1: On-going 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. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 030, 031, 032, 033, 034 and 035 This task is aligned with the following course learning outcomes: .01, .02, .04, .05, .06, .08, .09, .10 and .11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | 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. |
Assessment task 2: Equipment Technology Presentation
| Intent: | Pharmaceutical manufacturers must ensure their equipment is fit-for-purpose, but the scope extends far deeper than product processing. This assessment has been designed for you to apply GMP and technical knowledge to a piece of equipment, practice your assessing skills and demonstrate your oral communication skills in a simulated pharmaceutical manufacturing scenario. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 031, 032 and 034 This task is aligned with the following course learning outcomes: .01, .04, .05, .06, .08, .09, .10 and .11 |
| Type: | Presentation |
| Groupwork: | Group, group assessed |
| Weight: | 25% |
| Length: | 15 minutes plus 5 minutes for questions |
| Criteria: | Provided via Canvas |
Assessment task 3: User Requirements Specification Assignment
| Intent: | Advancing another step from assessment 2, this assessment relates closely to a real-life project scenario where a Production group have defined their needs and the Engineer (the student) will provide advice to take it further. The assessment allows you to demonstrate your ability to interpret requirements within the context of technical needs and GMP compliance. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 031, 034 and 035 This task is aligned with the following course learning outcomes: .01, .02, .04, .05, .06, .09, .10 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 1500 words (excluding references) |
| Criteria: | Provided via Canvas |
Assessment task 4: Technical note on Tablet Coating
| Intent: | The aim for this assessment is to provide opportunities for students to demonstrate how they can translate the knowledge gained into a practical training program through the use of a GMP operation process. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 030, 031, 033, 034 and 035 This task is aligned with the following course learning outcomes: .05, .06, .08, .09 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 1,000 to 1,500 words (excluding references) |
| 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)
Recommended texts
The PIC/s Code of GMP
Other relevant references as identified throughout course notes and lectures.