Process Development for Therapeutics (B) – A Perspective for Small Molecules

Unit Code:HES6407

Credit Points	Duration	Contact Hours	Campus	Prerequisite	Corequisite
12.5 Credit Points		30 Hours	Hawthorn	Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401and HES6402 is therefore desirable.	HES6401 International Good Manufacturing Practices and Quality Assurance HES6402 Good Manufacturing Practices for Manufacturing Operations

Credit Points

Duration

Contact Hours

Campus

Prerequisite

Corequisite

12.5 Credit Points

30 Hours

Hawthorn

Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401and HES6402 is therefore desirable.

HES6401 International Good Manufacturing Practices and Quality Assurance

HES6402 Good Manufacturing Practices for Manufacturing Operations

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 and Quality Management)

Aims & Objectives:

This unit of study aims:

To provide an understanding the necessity for quality assurance, good manufacturing practice, good laboratory practice and quality control in the pharmaceutical industry.
To develop an understanding process scale-up issues as pertains to the pharmaceutical industry.
To develop an understanding of process optimization and validation relating to process scale-up.

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

Provide a basic understanding of quality management for a small molecule pharmaceutical.
Illustrate a typical process reaction vessel and describe the issues that need to be addressed before scale-up of a chemical process.
Compare and contrast alternative synthetic routes to various API's (active pharmaceutical ingredients).

Teaching Methods:

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).

Assessment:

Test (10%)
Assignments (50%)
Exam (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:

Quality Assurance.
Requirements for Good Manufacturing Practice and Good Laboratory Practice.
Starting materials, product supply.
Scale-up issues: Reaction vessels, separations, volume measurements, samplings; Evaporation to dryness; Temperature; Isolation of products; Stability; Toxicity; Chromatography.
Choice of synthetic route: Starting materials; Safety; Environmental factors; Chromatography; Catalysis; Number of steps; Yield; Equipment; Convergent route; Robustness.
Various case studies of process development in the pharmaceutical industry.

Reading Materials:

Lecture notes (provided via Blackboard)

Textbooks:

Printed notes will be supplied.
Therapeutic Goods Administration, Australian code of good manufacturing practice for medicinal products, 16 August, 2002. Gadamasetti, KG (Ed), Process chemistry in the pharmaceutical industry