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.