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Studiegids

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

Vak
2021-2022

Admission requirements

Completed the first year of the master Bio-Pharmaceutical Sciences. 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 specialization.

Description

The course focuses on the development and production of sterile medicines. Knowledge of microbiology and the ability to implement this knowledge in the design and control of pharmaceutical production play an important role in this. Environmental factors and the quality of water also influence various steps in the production process and are discussed in detail.

Course objectives

After completion of this course students will have:

  • Knowledge and understanding of the biology of microorganisms and the implications for pharmaceutical production and quality control.

  • Understanding of the importance of design and control of sterile manufacturing.

  • Knowledge of environmental monitoring, sterilization methods, and sterility assurance.

  • Understanding of the role of the qualified person in assuring the quality of sterile pharmaceuticals.

Timetable

4-6 October, 2021.

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

Will be announced during the course.

Registration

Registration via the provider of the course. Registration via uSis is not necessary.

Contact

Coordinator for the Industrial Pharmacy specialization: Emily Ouwehand MA (email: studyadvisorBPS@lacdr.leidenuniv.nl).

Remarks

This course is only available for students of the Industrial Pharmacy specialization.

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