Single-Course English 5 ECTS

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

Overall Course Objectives

To provide the students with theoretical insight and understanding for GMP, hygiene and quality management systems. This involves legal requirements, relevant Standards and guidelines, audits and auditing, documentation and work methologies used in companies within the pharmaceutical, biotechnological and food industry.

Learning Objectives

  • 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.
  • Apply GMP rules and the ISO 9001 Standard for the preparation, execution and reporting of a audit simulation for a virtual pharma company
  • Utilize HACCP methology for risk assessment of pharma and food industry processes
  • Understand the design and qualification processes for pharmaceutical industry
  • Interpret a Pipe & Instrumentation diagram for production process and units to identify the important details with relevance to GMP and hygiene.
  • Understand the quality demands and standards for utility systems (e.g air, water and steam) to be in compliance with GMP and hygienic standards.
  • Understand cleaning principles for GMP compatable production plants.

Course Content

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. The team must prepare an audit preparation report, conduct an audit and prepare a final audit report. The latter report applies to 30% of the course evaluation.

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)

Recommended prerequisites

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

Teaching Method

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

Remarks

Guest lecturers from industry
The GMP course (formerly 28855) is divided into a practical version 28857 to 7.5 ECTS, and a theoretical version 28855 to 5 ECTS.
28857 are held autumn semesters and 28855 spring semesters.

Limited number of seats

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.

See course in the course database.

Registration

Language

English

Duration

13 weeks

Institute

Chemical Engineering

Place

DTU Lyngby Campus

Food
Course code 28855
Course type Candidate
Semester start Week 5
Semester end Week 19
Days Thurs 13-17
Price

7.500,00 DKK

Please note that this course has participants limitation. Read more

Registration