Good Manufacturing Practices for Manufacturing Operations
Unit code: HES6402
|Credit points||12.5 Credit Points|
|Duration||1 Semester or teaching period|
|Contact hours||30 Hours|
|Campus||External Venue, Hawthorn|
|Prerequisites||Admission to one of the GMP suite of postgraduate programs or equivalent|
Related course(s)A core 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) and an elective unit of study in the Master of Science (Biotechnology).
Aims and objectives
* State the underlying principles of GMP & Quality, their significance in the industry, and develop practical strategies to apply those principles in the workplace.
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:
- analysis skills,
- problem solving skills,
- communications skills,
- ability to tackle unfamiliar problems.
Definition of the cGMP requirements for facility & equipment cleaning, sanitation programs & records.