Quality Assurance, Biosafety

Data

Official data in SubjectManager for the following academic year: 2024-2025

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

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

-

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

• Elhusseiny Mohamed Mahmoud
• Fittler András Tamás

Instructor / tutor of practices and seminars

• Elhusseiny Mohamed Mahmoud
• Fittler András Tamás