Good Manufacturing Practice (GMP) and quality in pharmaceutical, biotech and food industry – Theoretical version

• Identify the necessary quality requirements imposed to an organisation and its buildings, production equipment, personnel and procedures of a pharmaceutical, biotech or food company, which is subject to follow GMP regulations, food regulations or ISO quality standards.
• Compare GMP, food and hygiene rules and Standards from various national and international regulatory authorities and standardization organizations and be familiar with their document structure.
• Understand the basic principles and importance of a Quality Management System (QMS) and its practical implementation in a pharmaceutical, food or biotech company.
• Understand the basic principles of hygienic design and compliance with GMP standards for pharmaceutical, food and biotech production facilities.
• Understand and select cleaning principles and establish cleaning procedures for hygienic process plants.
• Conduct risk assessments on production methods to control product quality, including identifying risks and establishing control methods.
• Understand and analyze quality requirements for utilities (water, steam and air) for compliance with GMP requirements within the pharmaceutical, biotech and food industries.
• Apply GMP regulations, ICH Q7 guidelines and the ISO 9001 standard when preparing, conducting and reporting a simulated audit for a virtual pharmaceutical company.

The course covers basic GMP requirements from international and Danishl authorities, as well as from the international standardization organizations endorsed by the authorities. The theory also covers the life cycle of medicine products, food safety sustainability, HACCP methods, ISO quality standards, quality management systems, document control, hygienic design and cleaning of process plants and GMP compliant utilities.

The teaching is a mixture of lectures, as well as group problem solving and group written reports

The practical reporting in the course is based on a simulated auditing exercise where the team will audit a virtual pharma company which is represented by the course teachers or a newly developed ChatGMP chatbot. The team must prepare an audit preparation report, conduct an audit and prepare a final audit report. The latter report is evaluated on pass/nonpass criterias.

In the auditing exercise, there is a special focus on general GMP rules and particularly on the guideline ICH Q7 “GMP for API” and the ISO 9001: 2015 Standard. Based on information about the virtual pharma company’s production processes and organizational structure, the team must make an audit plan and prepare audit questions. which is practiced during the actual audit session which takes place with the course teachers representing the pharma company.

To facilitate the understanding of GMP as a real team effort involving all professional disciplines in real life, the groups will usually be composed of students with different backgrounds and knowledge.

Peer reviews are part of the learning and evaluation methods for certain group work.

There is usually a half-day visit to a pharmaceutical company. (If possible due to Covod-19)

• 6 – 20 (Thurs 13-17)

B.Sc.+
Course in process technology/engineering (for instance 28020/28022)
Courses in biochemistry (27022, or 27032)

Common lectures. Problem solving and group work in groups of max. 5 persons. Group work outside module F1B is expected.

Guest lecturers from industry
The GMP course exist in two versions: The practical version 28857 to 7.5 ECTS, and the theoretical version 28855 to 5 ECTS. The courses are not supplementary.
28857 are held autumn semesters and 28855 spring semesters.

Minimum: 10, Maximum: 120.

Please be aware that this course has a minimum requirement for the number of participants needed, in order for it to be held. If these requirements are not met, then the course will not be held. Furthermore, there is a limited number of seats available. If there are too many applicants, a pool will be created for the remainder of the qualified applicants, and they will be selected at random. You will be informed 8 days before the start of the course, whether you have been allocated a spot.