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: 01-11-2022
Duration: 1 semester
Version: Archive
Comment
Entry requirements
Bachelor degree in Molecular Bioscience, Biomedicine, chemistry or pharmacy
The course cannot be chosen if you have passed, registered, or have followed FA809, or if FA809 is a constituent part of your Curriculum.
The course cannot be chosen if you have passed, registered, or have followed FA809, or if FA809 is a constituent part of your Curriculum.
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.
In relation to the qualification profile of the degree programme, the course explicitly focuses on:
- 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
Duration
2 hours
Examination aids
All common aids are allowed e.g. books, notes, computer programmes which do not use internet etc.
Internet is not allowed during the exam. However, you may visit the course site in itslearning to open system "DE-Digital Exam". If you wish to use course materials from itslearning, you must download the materials to your computer the day before the exam. During the exam you cannot be sure that all course materials is accessible in itslearning.
ECTS value
5
Indicative number of lessons
Teaching Method
The teaching method is based on three phase model. These teaching activities are reflected in an estimated allocation of the workload of an average student as follows:
- 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.
Teacher responsible
Timetable
Administrative Unit
Team at Educational Law & Registration
Offered in
Recommended course of study
Transition rules
Transitional arrangements describe how a course replaces another course when changes are made to the course of study.
If a transitional arrangement has been made for a course, it will be stated in the list.
See transitional arrangements for all courses at the Faculty of Science.