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Essay Quality Control/Quality Assurance

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

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

Semester 1, period 2.
The essay must be completed before the start of the internship in semester 2.

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 uSis for this course is not necessary.

Contact

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

Remarks

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

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