Good Manufacturing Practice in Pharmaceutical IndustryLaajuus (2 - 3 op)

Osaamistavoitteet

After completing the course the students will: - understand what the requirements for the quality of pharmaceuticals are and why quality is important - know the rules and laws (mainly EU-GMP and ICH documents) that control drug production - know how pharmaceutical quality assurance work is carried out in practice During the course, the following general skills will also be practiced: - Information-seeking skills - Problem-solving skills - Team work skills (in the extra 1 ECTS module)

Sisältö

This course covers the following topics: - Good Manufacturing Practice (EU); - Quality in drug production and product and process development: how to get good and robust processes in the manufacture of drugs through the application of e.g. Quality by Design (i.e. a systematic approach for product and process development) - GMP documents, such as ICH Q8, Q9, Q10, will be highlighted as well as their benefit to the pharmaceutical industry's operations

Esitietovaatimukset

No prerequisites.

Arviointikriteerit, tyydyttävä (1)

The student has achieved all the learning objectives at a satisfactory level of competence.

Arviointikriteerit, hyvä (3)

The student has achieved all the learning objectives at a good level of competence.

Arviointikriteerit, kiitettävä (5)

The student has achieved all the learning objectives at an excellent level of competence.

Oppimateriaalit

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines https://ec.europa.eu/health/documents/eudralex/vol-4_en