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 & Objectives:

This unit of study aims:

• To reinforce GMP practices when carrying out standard chemical procedures.
• To enhance the student's scientific skills by strengthening analytical chemistry as applied to the analysis of pharmaceuticals.
• To introduce the need and practice of appropriate validation in pharmaceutical analysis.

At the end of this unit of study students will be able to:

• Understand the essential difference between precision and accuracy and the importance of ensuring both.
• To apply correct validation and verification techniques during the analysis of of pharmaceutical and related materials.
• To quantitatively analyse specific samples for pharmaceutical content using various

Teaching Methods:

Lectures/tutorials, laboratory and/or experiential off-campus learning, web based unit presence (Blackboard).

Assessment:

• Mid-semester test (25%)
• Practical reports and/or assignments (35%)
• Final examination (40%)

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:

• Product characterisation.
• Standard procedures in analytical chemistry.
• GMP as applied to analytical chemistry.
• Particle sizing of dispersions and emulsions and its importance in validation.
• Good record keeping and laboratory practices in the measurement of emulsion and dispersion stability.

Reading Materials:

Lecture notes (provided via Blackboard)

Recommended Reading: