Process Development for Therapeutics (D) – Perspective for Pharmaceutical Finished Dose Forms
Unit code: HES6423
|Credit points||12.5 Credit Points|
|Duration||1 Semester or Teaching Period|
|Contact hours||30 hours|
|Campus||External Venue, Hawthorn|
Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402and HES6403 is therefore desirable.
Related course(s)An elective unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices) (Honours).
Aims and objectives
This unit of study aims to:
- Provide an understanding of the necessity for quality assurance, good manufacturing practice, good laboratory practice and quality control in the pharmaceutical industry.
- Develop an understanding of full scale manufacturing technologies.
- Develop an understanding of process optimisation and validation relating to process technologies for finished dose forms.
- On successful completion of this unit of study students will be able to:
- Provide a basic understanding of quality management for a pharmaceutical finished dose form.
- Describe the process conditions that impact quality for different dose forms such as topicals and solid dose forms.
- State process control and validation strategies for these dose forms.
Lectures/Tutorials, Laboratory and/or experiential off-campus learning, Case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, Web Based Unit Presence (Blackboard).
Generic skills outcomes
Students will be provided with feedback during the assessment for this unit of study on their progress in attaining the following generic skills:
- Teamwork skills,
- Analysis skills,
- Problem solving skills,
- Communications skills,
- Ability to tackle unfamiliar problems, and the
- Ability to work independently
- Quality Assurance of finished dose forms
- Requirements for Good Manufacturing Practice and Good Laboratory Practice
- Starting materials, product supply
- Solid dose forms
- Steps in manufacture
- Granulation technology
- Blending technology
- Particle Size
- Blend Uniformity
- Coating Technology
- Typical Dose Forms
- Formulation of creams and ointments
- Bulk manufacture
- Microbiological control.
- Various case studies of GMPs and finished dose forms in the pharmaceutical industry.