NPLK25005U Quality Assessment and Legislation - From Idea to Product

Volume 2025/2026
Education

MSc Programme in Biosolutions
MSc Programme in Biotechnology

Content

From invention to product release, several regulations and quality systems must be implemented and adhered to. This course provides students with knowledge of various quality assessment systems, such as ISO (Standardization), GMO, and GMP (Good Manufacturing Practice).

Key topics include intellectual property rights (IPR), regulations required for production, and the continuous need for quality assessments to ensure high production standards, continously assessing quality and compliance with international requirements.

Students will work examples from production and cases where they need to analyze how to establish and implement quality systems. They will also explore the global differences in standards and regulations..

In the course, students will gain insights into intellectual property rights and understand the legislative requirements across different regions.

Examples of course areas from idea to production include:

  • The IPR area and landscape.
  • Regulatory Frameworks: Legal and regulatory frameworks at the international, national, and local levels, how to interpret and apply these.
  • Production requirements, including GMO approval and environmental concerns.
  • Quality control tools and techniques , the principles of quality control and its significance across industries.
  • Quality Assurance Methodologies: Presentation of  various quality assurance models, such as ISO standards, and learn how these are implemented to improve processes and outputs.
  • Product/Service Standards: Definition, measuremets, and maintain product and service standards that align with industry regulations and meet customer expectations and safety.
  • Documentation and Reporting.
  • Introduction to the legal framework for the green deal on products.
Learning Outcome

By the end of this course students will have demonstrated the following knowledge, skills, and competences:

 

Knowledge:

  • Reflect on the required legislation, such as GMO regulations and food production standards, including national requirements.
  • Gain insight into Quality Assurance (QA) and Quality Control (QC),importance of GMP and including their definitions and applications.
  • Acquire theoretical knowledge of intellectual property rights (IPR).
  • Understanding the importance of IPR

 

Skills:

  • Be able to apply various quality control/assessment methods and evaluate when to use different methodologies and tools.
  • Explore a range of tools and techniques for quality control.
  • Be able to analyze production processes and apply relevant control actions, e.g.  GMP  and GMO regulations.

 

Competences:

  • Reflect on different forms of quality control/assessemt and how these are used.
  • Be able to take responsibility in work situations and collaborate with peers to make decisions on quality measures from idea to product.
  • Comprehending the necessary regulations for production.

See Absalon for course literature.

To successfully participate in this course within the "Biosolutions" program, students are recommended to have the following competences:
• A Bachelor's degree in biotechnology or related fields.
• Basic knowledge of plant biology and bioprocessing.
The course includes lectures, case studies, and a final report. Theoretical concepts, methods, and challenges from idea to product release are taught in lectures and through exercises. Students will suggest appropriate actions based on relevant legislation.

Guest lectures from industry professionals will provide insights into the requirements from idea to production.

Throughout the course, students will work in groups on case studies (supplied by industry where possible). The final report will require students to analyze a production case and demonstrate an understanding of key quality assessment systems and legislation.
  • Category
  • Hours
  • Lectures
  • 57
  • Preparation
  • 70
  • Practical exercises
  • 20
  • Project work
  • 50
  • Guidance
  • 8
  • Exam
  • 1
  • Total
  • 206
Continuous feedback during the course of the semester
  • Feedback on individual and group assignments.
  • Feedback during the final presentation and examination process.
Credit
7,5 ECTS
Type of assessment
Oral examination, 20 minutes
Type of assessment details
The oral exam will consist of a short pitch based on the case, followed be detailed questions and discussions of the curriculum.
Exam registration requirements

Hand in final report

Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Several internal examiners
Re-exam

Same as the ordinary exam.

If the requirements are not met the student need to hand in a report 3 weeks before the re-exam. Contact the course responsible for details.

Criteria for exam assesment

In order to obtain the grade 12, the student should convincingly and accurately demonstrate the knowledge, skills and conpetences described under Learning outcome.