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Abstract
Participants are introduced to the GMP basics which belong to the production environment of pharmaceutical products. The associated processes of the required quality management system are explained and supported with examples. The participants apply their knowledge in different scenarios.
Objective
Participants • understand where to get information about GMP requirements • know the main processes of a GMP quality management system • can identify risk-based requirements for equipment or clean-rooms • know how to interpret project plans up to "first in man" • know the effort involved in outsourcing manufacturing • understand the processes involved in obtaining an analytical result
Content
• The GMP world - everything available on the Internet, who can still see through? • GMP suitable quality management system - the main processes made easy • Equipment and cleanrooms - risk-based consideration of what is needed • Manufacturing processes thought through to the end • Outsourced manufacturing - I don't want to do anything myself, is that possible? • Quality control and release - how to avoid testing into compliance
General Information
- Language
- English
- Levels
- NDS , WBZ
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Production / GMP
Does not take place this semester.
|
No time listed | 35 h semesterly |