Good Manufacturing Practice in Pharmaceutical IndustryLaajuus (2 cr)

Objective

Learning objectives - after completing the course the students will: - understand what the requirements for the quality of pharmaceuticals are and why quality is important - know the EU-GMP principles that control drug production - understand how pharmaceutical quality assurance work is carried out in practice Transferable skills - during the course, the following transferable skills will also be practiced: - Information-seeking skills - Problem-solving skills

Content

- Basics of pharmaceutical quality requirements - Good Manufacturing Practice guidelines (EU)

Qualifications

No prerequisites.

Assessment criteria, satisfactory (1)

Grade 1: The student - shows an adequate but limited understanding of what the requirements for the quality of pharmaceuticals are and why quality is important - shows adequate but limited knowledge of the EU-GMP principles that control drug production - shows an adequate but limited understanding of how pharmaceutical quality assurance work is carried out in practice Grade 3: The student - shows a good understanding of what the requirements for the quality of pharmaceuticals are and why quality is important - shows accurate knowledge on the EU-GMP principles that control drug production - shows a good understanding of how pharmaceutical quality assurance work is carried out in practice Grade 5: The student - shows in-depth understanding of what the requirements for the quality of pharmaceuticals are and why quality is important - shows accurate and detailed knowledge on the EU-GMP principles that control drug production - shows a good understanding of how pharmaceutical quality assurance work is carried out in practice