BMB839: Good Manufacturing Practice (GMP) in the pharmaceutical industry
Study Board of Science
Teaching language: Danish
EKA: N210047102
Assessment: Second examiner: None
Grading: Pass/Fail
Offered in: Odense
Offered in: Spring
Level: Master
STADS ID (UVA): N210047101
ECTS value: 5
Date of Approval: 23-10-2018
Duration: 1 semester
Version: Archive
Comment
Entry requirements
Academic preconditions
The students are expected to have a basic understanding of biochemistry, molecular biology and chemistry, and be able to participate actively in discussions of the topics.
Participant limit
Course introduction
The aim of the course is to give the student knowledge of the legislation that applies for manufacturing of medicinal products.
This enables the students to understand and interpret the legislation in relation to the specific manufacturing.
The course builds upon the basic skill acquired during a BSc.
- Give competence to be a significant partner in matters of quality development and control
- Give knowledge of the current legislation for GMP, and understand hw the legislation can be interpreted and implemented.
Expected learning outcome
The learning objective of the course is that the student demonstrates the ability to:
- Have an overview of the current legislation for GMP
- Understand how the legislation can be interpreted and implemented
Content
The following main topics are contained in the course:
- Quality understanding and GMP-mindset
- Risk management
- Quality Management, Quality Assurance and Quality Control
- Requirements for personnel, premises and equipment
- Handling of materials
- Documentation, handling of quality defects and traceability
- Self-inspection and Quality Oversight
Literature
Examination regulations
Exam element a)
Timing
June
Tests
Written exam
EKA
N210047102
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Student Identification Card
Language
Normally, the same as teaching language
Examination aids
Not specified, a closer description of the exam rules will be posted under 'Course Information' on Blackboard.
ECTS value
5
Additional information
The examination form for re-examination may be different from the exam form at the regular exam.
Indicative number of lessons
Teaching Method
The teaching method is based on three phase model.
Intro phase: 30 hours
Skills training phase: 30 hours, hereof tutorials: 25 hours and excursion: 5 hours
The intro- and skills training phase will melt together in a combination of teoretical lectures, check tasks and case work. Furthermore, there will be elements of online teaching as webinars, online dialogues and written collaboration cases.
Activities during the study phase:
- Read relevant literature in the form of legislation and guidelines
- Prepare written assignments
- Conduct e-learning