Good Manufacturing Practice
Syllabus, Master's level, 3DR409
- Code
- 3DR409
- Education cycle
- Second cycle
- Main field(s) of study and in-depth level
- Medical Nuclide Techniques A1N
- Grading system
- Fail (U), Pass (G)
- Finalised by
- The Master Programmes Board of the Faculty of Medicine, 8 September 2023
- Responsible department
- Department of Immunology, Genetics and Pathology
Entry requirements
A Bachelor's degree, equivalent to a Swedish Kandidatexamen, from an internationally recognised university in life sciences (e.g. physics, radiophysics, chemistry or biology), medicine, pharmacy, nursing, or other relevant university education. All applicants need to verify English language proficiency equivalent to the Swedish upper secondary course English 6.
Learning outcomes
Knowledge and understanding
On completing the course, the student shall demonstrate the ability to:
- describe the basic concepts and purpose of Good Manufacturing Practice (GMP)
- describe how the rules for manufacturing drugs for clinical trials differ from commercial manufacturing
- explain the concepts of quality control and quality assurance
- describe the difference between audit and inspection
- explain the principles behind qualifications and validations
Competence and skills
On completing the course, the student shall demonstrate the ability to:
- present formal requirements from authorities on GMP for medical drugs, with focus on the laws and regulations for that apply to the preparation of sterile drugs
- describe requirements for microbiological quality control, aseptic production, localities, clothing etc.
- carry out simpler risk analyses/risk assessments in accordance with GMP
- carry out construction of quality systems
Judgement and approach
On completing the course, the student shall demonstrate:
- evaluate whether a working method, process or method is in accordance with good manufacturing practice
Content
The course aims to provide basic knowledge of the regulations that govern the manufacture of pharmaceuticals. The course focuses on the manufacture of sterile drugs with an extra focus on radiopharmaceuticals and biological drugs. The special requirements relevant for investigational medicinal products are also discussed. The course takes its point of departure in Swedish and European legislation and primarily describes the regulations that apply in the EU, but also differences and similarities with the rest of the world, and mainly the USA, are covered.
The course gives students the skills to understand the basic principles of, and be able to contribute to the development of, a quality system. The students also receive the prerequisites for independently searching, interpreting, and evaluating guidelines and legal texts in the area. The course provides the students with working tools and knowledge about the fundamental concepts used in quality work in a thorough way.
A number of questions and requirements are addressed during the course's seminars, which also include generic competencies and professional skills such as information retrieval and presentation techniques with the aim of preparing the student for future working life.
Instruction
Lectures, study visits/demonstrations as well as mandatory seminars and assignments.
Assessment
Models of assessment
Written exam, assignments and seminars.
Exceptions to modes of assessment
If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.
Requirements for a passing grade
Passing the course requires a passing result in the written examination and assignments, as well as passing participation in the mandatory elements.