Quality Assurance, Biosafety

Data

Official data in SubjectManager for the following academic year: 2022-2023

Topic

Quality assurance and quality management often come to mind in pharmaceutical manufacturing, yet quality can be extended to all things of value. Ensuring the quality of products or services, increases the competitiveness of the organization. Within the framework of the subject, students have the opportunity to get acquainted with the concept of quality, the development of quality management systems and the principles of quality management. The process approach and its significance, as well as the quality loop (PDCA principle) as a basis for quality management thinking. Further, course covers the general aspects of quality management layers, adapting GMP, ISO and external quality assurance in the research, diagnosis and manufacture of biopharmaceutical products. In addition, the course provides the student with a basic understanding of how to integrate these aspects into the latest molecular therapies, molecular diagnostics, and other biotechnology products. Finally, the course provides insight into quality risk management, product recall management, product stability, and end product quality.

Lectures

Practices

Seminars

• 1. Introduction, development of quality management, GMP and ISO
• 2. Safety first! Personal protective equipment, labelling and waste disposal
• 3. Pharmaceutical and biotech research quality
• 4. Designing quality assurance plan for research
• 5. Constructions, personal quality assurance
• 6. Building standards: using software and lego
• 7. General EU legislative basis
• 8. Quality levels case study, Internal and external environment, and stakeholders
• 9. Quality management in biotech production
• 10. Risk assessment techniques
• 11. Quality Risk Management
• 12. Recalling and processing a product
• 13. Complaint and recall handling
• 14. Testing recalled product and Stability testing
• 15. Product characterization
• 16. Testing impurities
• 17. On-going stability testing
• 18. Nucleic acid analysis
• 19. Biotech products for human use and what to monitor
• 20. Protein analysis
• 21. Biotech products for diagnosis and research
• 22. Monoclonal antibody quality assurance
• 23. Application of the Deming Cycle (Plan-Do-Check-Act)
• 24. Cytotoxic conjugated antibodies quality assurance
• 25. Molecular diagnostics quality
• 26. Molecular diagnostics, biotech or not?
• 27. Final product quality testing
• 28. Final test

Reading material

Obligatory literature

Literature developed by the Department

List of study aids to acquire curriculum (books, notes, other) and all presentations can be downloaded from MS teams and/or Neptun MeetStreet.

Notes

Recommended literature

Pharmaceutical Manufacturing Handbook (ISBN: 978-0-470-25959-7) chapters: 2.1, 3.1, 3.3, 5.1, 6, 7 .
Handbook: Quality Practices In Basic Biomedical Research (ISBN: 9780198777069) chapters: 1, 2.1.2, 4.3, 4.6.1
Molecular diagnostics chapters: 1 and 2
The Rules Governing Medicinal Products in the European Union EudraLex Chapter 6: Quality Control
https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf
https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapies/legal-framework-advanced-therapies

Conditions for acceptance of the semester

Maximum of 25 % absence allowed

Mid-term exams

In case of unsuccessful or missed end-of-the term test, a retake opportunity is granted to make up during the last week of the
semester. Assessment of the student performance is carried out according to a ve-grade scale: 100-86,1% -excellent (5); 86-77,1% -good (4); 77- 68,1% -satisfactory (3); 68-60,1% -pass (2); and below 60,0% -fail (1) respectively

Making up for missed classes

Retake opportunity is possible following personal discussion for the end-of-the term test.

Exam topics/questions

In-class and inter-class individual assignments, case studies, case discussions must be completed to learn the principles and quality techniques of quality management, and illustrate the biotechnological aspects of quality assurance.

Examiners

• Dr. Fittler András Tamás
• Elhusseiny Mohamed Mahmoud

Instructor / tutor of practices and seminars

• Dr. Fittler András Tamás
• Elhusseiny Mohamed Mahmoud