BMB839: Good Manufacturing Practice (GMP) in the pharmaceutical industry

The Study Board for Science

Teaching language: Danish
EKA: N210047102
Assessment: Second examiner: None
Grading: Pass/Fail
Offered in: Odense
Offered in: Spring
Level: Master

STADS ID (UVA): N210047101
ECTS value: 5

Date of Approval: 23-10-2018


Duration: 1 semester

Version: Archive

Entry requirements

Bachelor degree in Molecular Bioscience, Biomedicine, chemistry or pharmacy

Academic preconditions

The students are expected to have a basic understanding of biochemistry, molecular biology and chemistry, and be able to participate actively in discussions of the topics.

Participant limit

32

Course introduction

The aim of the course is to give the student knowledge of the legislation that applies for manufacturing of medicinal products.
This enables the students to understand and interpret the legislation in relation to the specific manufacturing. 
The course builds upon the basic skill acquired during a BSc.

In relation to the qualification profile of the degree programme, the course explicitly focuses on:
  • Give competence to be a significant partner in matters of quality development and control
  • Give knowledge of the current legislation for GMP, and understand hw the legislation can be interpreted and implemented.

Expected learning outcome

The learning objective of the course is that the student demonstrates the ability to:
  • Have an overview of the current legislation for GMP
  • Understand how the legislation can be interpreted and implemented.

Content

The following main topics are contained in the course:
  • Quality understanding and GMP-mindset
  • Risk management
  • Quality Management, Quality Assurance and Quality Control
  • Requirements for personnel, premises and equipment
  • Handling of materials
  • Documentation, handling of quality defects and traceability
  • Self-inspection and Quality Oversight

Literature

See itslearning for syllabus lists and additional literature references.

Examination regulations

Exam element a)

Timing

June

Tests

Written exam

EKA

N210047102

Assessment

Second examiner: None

Grading

Pass/Fail

Identification

Student Identification Card

Language

Normally, the same as teaching language

Duration

2 hours

Examination aids

Not specified, a closer description of the exam rules will be posted in itslearning.

ECTS value

5

Additional information

The examination form for re-examination may be different from the exam form at the regular exam.

Indicative number of lessons

60 hours per semester

Teaching Method

The teaching method is based on three phase model. These teaching activities are reflected in an estimated allocation of the workload of an average student as follows:
  • Intro phase: 30 hours
  • Skills training phase: 30 hours, hereof tutorials: 25 hours and excursion: 5 hours
The intro- and skills training phase will melt together in a combination of teoretical lectures, check tasks and case work. Furthermore, there will be elements of online teaching as webinars, online dialogues and written collaboration cases.    

Activities during the study phase:
  • Read relevant literature in the form of legislation and guidelines
  • Prepare written assignments
  • Conduct e-learning.

Teacher responsible

Name E-mail Department
Camilla Lundbye Castle clc@pharmakon.dk

Timetable

Administrative Unit

Biokemi og Molekylær Biologi

Team at Educational Law & Registration

NAT

Offered in

Odense

Recommended course of study

Profile Education Semester Offer period