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Studiegids

nl en

Basic Good Manufacturing Practices (GMP)

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

In the GMP (Good Manufacturing Practice) guidelines the principles of good manufacturing processes in the (bio)pharmaceutical industry are laid down to ensure the quality and safety of medicinal products. This course will cover the basic principles of GMP and its application in the pharmaceutical production process.

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 and principles.

  • Provide sufficient background to understand the meaning of GMP compliance and mistakes.

Course objectives

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

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

  • Describe and explain the commonly used technical terms in GMP.

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

    Timetable

This course is scheduled by the Hogeschool Leiden. The specific dates are not available yet.

### Mode of instruction

Lectures, tutorials (case discussion), self-tuition.

### 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.

### Registration

Registration via uSis is not necessary for this course.

Contact

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

Remarks

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

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