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GMP voor het Middenkader


Admission requirements

Only for students of the specialisation Industrial Pharmacy. Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation.


This course gives an overview of the most important aspects of quality control. It deals with the essential elements of the quality system and the supporting activities such as validation, qualification and change control. The course is adjusted to the most recent developments in the field of GMP concerning the changes in the European guidelines

This course aims to:

  • Raise the awareness of the importance of GMP in ensuring the quality and safety of medicinal products.

  • Provide an overview of the GMP terms, principles and laws.

  • Implement GMP in pratice, including quality culture

  • Learning to effectively engage with the specific position of the middle section in a pharmaceutical organisation.

Course objectives

At the end of this course the student is able to:

  • Describe and explain the GMP principles in the pharmaceutical production process.

  • Have insight in the 'wholes' within the organisation concerning GMP

  • Identify GMP compliance and mistakes in the production process of a medicinal product.


This course is offered by PCS and starts on September 19, 2023 and last three days in Van der Valk in Utrecht.

Mode of instruction

Lectures and tutorials (case discussion)

Assessment method

This course will be concluded by a pass/no pass based on participation in all components of the course. Students must provide a certificate for the result to be registered in uSis.

Reading list

Will be announced during the course.


Enrollment via My StudyMap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).


Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen,


This course is only available to students of the Industrial Pharmacy specialisation.

This information is without prejudice. Alterations can be made for next year.