Fundamentals of Process Analytical Technology
Unit code: HES6426
| Credit points | 12.5 Credit Points |
| Duration | 1 Semester or Teaching Period |
| Contact hours | 30 Hours |
| Campus | External Venue, Hawthorn |
| Prerequisites | Admission to the Graduate Certificate of Science (Good Manufacturing Practices) or equivalent |
| Corequisites | Nil |
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
At the end of this unit students will be able to:
- Critically evaluate the fundamental principles and expectations of the PAT initiative on a business and regulatory level.
- Describe the implementation of selected analytical technologies in an At-line, On-line or In-line capacity, outlining the benefits of each mode of implementation.
- Analyse data obtained from process analysers using quantitative, semi-quantitative and qualitative techniques.
- Demonstrate skills in writing reports. Research, assess and evaluate information. Evaluate data and identify facts.
Teaching methods
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
Content
A historical perspective of the PAT initiative and its related guidelines
Process maps as applied to PAT implementation
Process maps as applied to PAT implementation
Presenting business cases for PAT implementation.
Risk and critical control points
A review of process analysers and some applications.
An introduction to statistical methods used in conjunction with PAT and process control.
Near Infrared (NIR) Spectroscopy as applied to solid dose manufacturing
Design of Control and Monitoring Systems using PAT.
Reading materials
ICH Q9: Quality Risk Management November 2005
FDA Guidance: PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. September 2004
Pharmaceutical CGMPs for the 21st Century- A Risk-Based Approach, Final Report, September 2004
FDA Guidance: PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. September 2004
Pharmaceutical CGMPs for the 21st Century- A Risk-Based Approach, Final Report, September 2004
Lecture notes (provided via Blackboard).
