Course info

On this online course you will learn about the basics of current Good Manufacturing Practice (cGMP) that is followed in pharmaceutical companies.

The course is available both in spring and autumn.

If you wish to take the course in spring, please contact Hongbo Zhang (hongbo.zhang@abo.fi) or if in the autumn, please contact Outi Salo-Ahen (osalo@abo.fi).

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Learning outcomes:
After the completed course, you will 

• understand what the requirements for the quality of pharmaceuticals are and why quality is important
• know the rules and laws (mainly EU-GMP) that control drug production
• know how pharmaceutical quality assurance work is carried out in practice

Course time table: 
The course lasts for ca. 6-7 weeks.

• In spring 2023 the course starts on the 9th of January and finishes on the 3rd of March with the final exam at 13-16 (online).
• In autumn 2023 it is possible to complete the course according to your own timetable during 11/09/2023-15/12/2023. The final exam can be taken online on the following dates: 9th October, 13th November or 15th December 2023 at 9-12.   

Study methods: 

Individual studies, learning diary, quizzes, online expert lecture

Study material:

• Eudralex Volume 4
• Lundén Anna, Handbok i GMP (The GMP handbook), Key2Compliance AB
• Other material given on the course’s Moodle page.

Prior knowledge: not required

Study load:
Individual studies 50 h
Exam 3 h
Total: 53 h (2-3 ECTS)

Examination and grading:

• All online assignments should be completed to pass the course.
• Final exam (online) - max. 30 p. 
• Grading: 
  15 – 17 points = grade 1
  18 – 20 p. = 2
  21 – 24 p. = 3
  25 – 27 p. = 4
  28 – 30 p. = 5