Good Manufacturing Practice (GMP) and quality in pharmaceutical, biotech and food industry – Practical 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) with a view to complying with GMP requirements within the pharmaceutical, biotech and food industries.
• Based in a physical pilot plant representing a typical pharmaceutical unit operation, in groups of 4 students establish user requirements (URS) and prepare documents for carrying out practical tests on the plant for hygienic control and qualification according to GMP principles.

The course comprises basic GMP requirements from international and Danish legal 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 process design, Cleaning in Place systems and GMP compliant utilities.
The practical reporting of the course will contain two team rapports. One based on a practical exercise for a pilot plant CIP unit and the other report which is based on the study of a physical pilot unit. The latter report is constructed in steps during the course to generate a final comprehensive qualification and validation report for a pharmaceutical production unit using proper document control protocols.

A special focus is on the science and risk based approach to GMP, the Quality by Design and Design Space concepts, used to modernize and make the pharmaceutical industry more efficient and competitive.

The teaching is a mix of lectures, problem solving, group works and practical exercises in the pilot plant To enforce the understanding of GMP as a true team effort along all professional disciplines in real life, the teams will normally be composed of students with different background and knowledge.
Peer reviews of some group works are part of the learning and evaluation methods.

• 36 – 49 (Thurs 13-17)
• 36 – 49 (Fri 13-17)

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

Common lectures. Group work, problem solving and pilot lab exercises in groups of max. 4 persons. Group work outside modul E1B is expected.

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

Minimum: 10, Maximum: 56.

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.