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Quality Management and Production
Last Updated: 2026-06-01 11:33:49
Abstract
Quality Management and Production in the pharmaceutical industry integrates design, planning, execution, and control of manufacturing processes to release products of a predetermined quality. The module offers introductory lectures and workshop-like teaching of case studies on quality in the pharmaceutical production.
Objective
1. Students can explain the pharmaceutical quality system considering plants, processes, and personnel based on international quality related guidelines. 2. Students can explain the role, responsibilities, and competencies of a qualified person with special focus on release requirements for a pharmaceutical product. 3. Students can describe the validation of a manufacturing process based on 'quality-by-design' principles. 4. Students can describe quality aspects of packaging and stability. 5. Students can explain quality risk management measures.
Content
The following areas will be covered: quality culture and organization, regulatory requirements, quality risk management, qualification and validation, quality-by-design, process development, manufacturing, documentation.
Resources
Lecture Notes
Handouts as electronic files
General Information
- Language
- English
- Levels
- MSC
- Frequency
- Yearly recurring
Examination
- Type
- graded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Quality Management and Production
Block course (see special program)
Room HCP E47.2
|
No time listed | 32 h semesterly |
Offered In
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Industry-Specific Training (Please consult schedule on the website of the study programme )
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