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Quality Management in Pharma and Biotech. Module 3 - Sterile Manufacturing


Admission requirements

Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation. Only available to students of the Industrial Pharmacy specialisation. The course GMP voor het Middenkader must be completed.


This module focuses on process design and control for manufacturing of sterile pharmaceuticals. The challenging environment in production requires expertise in microbiology and control systems specific for sterile manufacturing. Implementation of this expertise in the design and control of processes is crucial. Contamination factors and environmental control both influence several steps in the production process and will be discussed extensively.

Course objectives

After completion of this course students can:

  • Apply the principles of specific sterility related subjects, such as monitoring, cleaning and disinfection, sterilization, and validation.

  • Interpret the guidelines and common practices, and distinguish these facts from myths.

  • Demonstrate a critical attitude towards sterility assurance in sterile manufacturing.


This course is offered by PCS and starts October 31st until November 2 in Van Der Valk Vianen

Mode of instruction

Lectures, self-tuition, discussion.

Assessment method

This course will be concluded by a written exam and an assignment. Each counting for 50% of the final grade.

For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 5.5 to successfully complete this course.

Reading list

Eudralex Vol. 4, Annex 1: Manufacture of Sterile Products.


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 for students of the Industrial Pharmacy specialisation.

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