Admission requirements
This course is only for students of the Industrial Pharmacy specialisation. The course GMP voor het Middenkader must be completed.
Description
Quality management and adherence to GMP guidelines in the pharmaceutical production process are essential to ensure that the batches of drugs that are released are of the required identity, quality, and purity for the intended use of the product. The Essay Quality Control/Quality Assurance focuses on critical release factors of drugs and aims to prepare the student for the Internship Quality Control/Quality Assurance. Therefore, the subject of the essay is geared to the internship, so that, for example in preparation for an internship at HAL Allergy B.V. the control of individual patient preparations is being considered, while in preparation for an internship at Janssen Biologics the special production aspects of sterile human monoclonals is covered. The is written under the supervision of the internship supervisor (Qualified Person or related position in quality control and assurance) and should be completed in approximately 5 weeks.
Course objectives
After completion of this course students will have:
Demonstrated knowledge and understanding of the legal and professional responsibilities of a Qualified Person with regards to risk-based decision making for the release of a pharmaceutical product.
Demonstrated knowledge and understanding of the chain of systems, including deviation and chance control systems in the manufacturing process of a pharmaceutical product ensuring the quality of individual batches.
Demonstrated knowledge and understanding of critical release factors of ‘own product’.
Written a well-structured assay demonstrating a broad view and critical attitude towards the subject area.
Timetable
The essay is scheduled for semester 1, period 2.
In MyTimetable, you can find all course and programme schedules, allowing you to create your personal timetable. Activities for which you have enrolled via MyStudyMap will automatically appear in your timetable.
Additionally, you can easily link MyTimetable to a calendar app on your phone, and schedule changes will be automatically updated in your calendar. You can also choose to receive email notifications about schedule changes. You can enable notifications in Settings after logging in.
Questions? Watch the video, read the instructions, or contact the ISSC helpdesk.
Note: Joint Degree students from Leiden/Delft need to combine information from both the Leiden and Delft MyTimetables to see a complete schedule. This video explains how to do it.
Mode of instruction
Self-tuition.
Assessment method
This course will be completed with a report. The report is assessed by the internship supervisor and a BPS staff member on the basis of a standard form.
The grade is expressed by using a decimal integer between 1.0 and 10.0 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 6.0 to successfully complete this course.
Reading list
Subject to the content of the essay.
Registration
Registration via MyStudyMap for this course is not necessary.
Contact
Coordinator of the industrial Pharmacy specialisation: t.b.d.
Examiner: Dr. Faisal Aiobi (f.aiobi@lacdr.leidenuniv.nl)
Remarks
This course is only for the students of the Industrial Pharmacy specialisation.
The essay must be completed before the start of the internship in semester 2.
This information is without prejudice. Alterations can be made for next year.
Software
Starting from the 2024/2025 academic year, the Faculty of Science will use the software distribution platform Academic Software. Through this platform, you can access the software needed for specific courses in your studies. For some software, your laptop must meet certain system requirements, which will be specified with the software. It is important to install the software before the start of the course. More information about the laptop requirements can be found on the student website.