Course Title: Medicine Manufacture and Quality Evaluation
Part A: Course Overview
Course Title: Medicine Manufacture and Quality Evaluation
Credit Points: 12.00
Course Coordinator: .
Course Coordinator Phone: +61 3 9925
Course Coordinator Email: @rmit.edu.au
Pre-requisite Courses and Assumed Knowledge and Capabilities
Required Prior Study
You should have satisfactorily completed the following course/s before you commence this course.
- PHAR1038 Medication Formulations 2
Alternatively, you may be able to demonstrate the required skills and knowledge before you start this course.
Contact your course coordinator if you think you may be eligible for recognition of prior learning.
Course Description
In this course, you will advance your knowledge in the principles of medicine formulations to the quality evaluation and analysis of medicines.
You will integrate your knowledge of medicine formulations to the sterile and cytotoxics and the clean rooms used for their manufacture. A significant focus of this course is directed towards developing the knowledge of and applying the analytical techniques and tests used to evaluate the quality of different medicine formulations both in theory and in the lab.
In this course you learn about the kinetics, stability, Good Manufacturing Practice (GMP) and Quality Assurance (QA) requirements by the regulatory body of medicine locally and globally.
You will practice the extemporaneous preparation of advanced formulations including sterile formulations encountered in pharmacy practice, together with requisite documentation, labelling, packaging and counselling requirements.
Please note, your overall mark in this course will contribute to the calculation of the weighted average mark (WAM).
See the WAM information web page for more information.
Objectives/Learning Outcomes/Capability Development
Program Learning Outcomes
This course contributes to the program learning outcomes for the following programs:
Bachelor of Pharmacy (Hons)
PLO 1 Apply breadth and depth of pharmaceutical and health science theories, concepts and evidence in various real world settings using a scientific approach to improve patient and population health.
PLO 2 Apply and critically evaluate evidence-based pharmaceutical and health knowledge and skills to conceptualise and deliver safe and effective practice in a variety of contexts, independently and collaboratively, with emerging technological advancements
PLO 5 Communicate to diverse audiences utilising contemporary and traditional formats employing integrity, inclusivity and culturally safe practices to ensure patient-centred care.
PLO 8: Demonstrate an ability to formulate, prepare, and deliver medications, therapeutic products, and services according to ethical codes and practice guidelines
For more information on the program learning outcomes for your program, please see the program guide.
Upon successful completion of this course, you will be able to:
- Apply knowledge of kinetics and mechanisms of chemical degradation to solve problems in the stability of medicine formulations; including investigate, evaluate and report the physical characteristics of formulations including release kinetics and relate these to quality control and pre formulation requirements.
- Compare the application of quality control, quality assurance and the principles of good manufacturing practice to regulation of medicine production in Australia and internationally.
- Review and evaluate the formulation and preparation of cytotoxic medicines and sterile products to environmental control, risk assessment and the clinical outcome for the patient.
- Prepare extemporaneous formulations safely and accurately
- Critically analyse professional standards in relation to schedules of medicines and controlled substances, Pharmaceutical Benefits Scheme (PBS) registration, advertising, and pharmacovigilance.
Overview of Learning Activities
You will be actively engaged in a range of learning activities such as lectorials, tutorials, practicals, laboratories, seminars, project work, class discussion, individual and group activities. Delivery may be face to face, online or a mix of both.
You are encouraged to be proactive and self-directed in your learning, asking questions of your lecturer and/or peers and seeking out information as required, especially from the numerous sources available through the RMIT library, and through links and material specific to this course that is available through myRMIT Studies Course.
Overview of Learning Resources
RMIT will provide you with resources and tools for learning in this course through myRMIT Studies Course.
There are services available to support your learning through the University Library. The Library provides guides on academic referencing and subject specialist help as well as a range of study support services. For further information, please visit the Library page on the RMIT University website and the myRMIT student portal.
Overview of Assessment
Assessment Tasks
This course contains hurdle requirements. All hurdle requirements for this course are indicated clearly in the assessment regime that follows, against the relevant assessment task(s) and all have been approved by the College Deputy Vice-Chancellor (Learning & Teaching).
Assessment Task 1: Module Quizzes
Weighting (20%)
This assessment task supports CLOs 1,2
Assessment Task 2: Applied Case studies
Weighting (20%)
This assessment task supports CLOs 1,2,3, and 5
Assessment Task 3: Practical Compounding Assessments
The final assessment in this series of compounding practicals is a hurdle requirement to ensure you have mastered the extemporaneous compounding competency as required by the Pharmacy Board of Australia.
Weighting (40%)
This assessment task supports CLOs 1,2, 4 and 5
Assessment Task 4: Applied Case studies
Weighting (20%)
This assessment task supports CLOs 1,2,3, and 5
If you have a long-term medical condition and/or disability it may be possible to negotiate to vary aspects of the learning or assessment methods. You can contact the program coordinator or Equitable Learning Services if you would like to find out more