Unit code: HES6409
|Credit points||12.5 Credit Points|
|Duration||1 semester or teaching period|
|Contact hours||30 Hours|
|Campus||External Venue, Hawthorn|
|Prerequisites||Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402 and 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 and Quality Management).
Aims and objectives
This unit of study aims to extend the principles presented in HES6403 to practical outcomes. At the end of this unit of study students will be able to:
Statistical Data Analysis:
- Understand the meaning of statistical terminology.
- Use hypothesis tests to compare data against validation acceptance criteria.
- Perform tests for outliers.
- Perform test for Variance ('F' tests).
- Perform tests for Means ('t' tests).
- Analyse attribute data (X2).
- State the GMP reasons for cleaning validation.
- Answer the question - what is clean ?
- Prepare a cleaning validation protocol outline.
- Define rational acceptance criteria.
- Calculate a cleaning limit from practical examples.
Preparing Validation Protocols - Practical workshops
- Understand current cGMP requirements for process validation.
- Identifying critical process steps.
- Distinguish between process vs product validation.
- Prepare a process validation protocol.
- Write reports consistent with FDA, EU & TGA requirements.
- Prepare a protocol draft for review.
Validation of Solid Dose Forms and Liquids/Creams
- State the critical steps requiring process validation of tablets.
- State the critical steps requiring process validation of liquids and creams.
- Apply risk assessment to process validation of these dose forms.
- List acceptance criteria.
- State the requirements for blend uniformity.
Validation of Biotechnology Products
- State the critical steps requiring process validation of fermentation.
- State the critical steps requiring process validation of chromatography.
- Develop a process validation plan for a typical biotech manufacturing pathway.
- List typical industry acceptance criteria.
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
Cleaning Validation: This module covers the cGMP requirements for cleaning validation programs and includes a review of FDA guidelines.
Validation of Solid Dose Forms and Liquids/Creams: This module covers the requirements for process validation of oral dose forms including tablets, liquids and creams.
Reading materialsA comprehensive Validation Reference Manual with detailed notes
Industry Guidelines on Validation
Case Study and Workshop materials
Lecture notes (provided via Blackboard)