Good Laboratory Practices (for Non-Clinical Laboratories)
Unit code: HES6410
|Credit points||12.5 Credit Points|
|Duration||1 Semester or Teaching Period|
|Contact hours||30 Hours|
|Campus||External Venue, Hawthorn|
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 introduce Good Laboratory Practices (GLP) to R&D laboratory managers, supervisors and other interested students, particularly those who are involved in regulated laboratories operating under GLPs. At the end of this unit of study students will be able to:
- Review of FDA Regulations & Controls
- List the scope of FDA control.
- Describe the difference between guides and regulations.
- Describe the regulatory review process for registrations and GLP/GMP compliance.
- Describe the role of the QA Unit in a GLP laboratory.
- Review of FDA CFR 58 and OECD GLP Regulations
- Understand the content and intent of CFR 58.
- Using CFR 58, locate the clauses relating to specific GLP requirements
- GLPs and Documentation Compliance – Protocols, Records and Reports
- State the required contents of a study protocol.
- State the required contents of a study report.
- State the requirementsfor securing and protecting data.
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
- Review of FDA Regulations & Controls: This module is designed to provide participants with a better understanding of the regulatory role and controls exercised by FDA. The module explains how a regulatory audit is conducted.
- Review of FDA CFR 58 and OECD GLP Regulations: This module is designed to provide participants with detailed understanding of the CFR 58 GLP regulations.
- GLPs and Documentation Compliance – Protocols, Records and Reports : This module is designed to provide participants with the GLP requirements for compliant documentation.
- A Workshop will be held to evaluate an example protocol against CFR 58 requirements and to interpret FDA warning letters compared to the CFR 58 regulations.