Quality Assurance, Biosafety

Data

Official data in SubjectManager for the following academic year: 2026-2027

Topic

The Quality Assurance and Biosafety course at the University of Pécs Faculty of Pharmacy is designed to equip Biotechnology BSc students with essential knowledge and skills in quality management and biosafety practices. This comprehensive course includes a broad range of essential topics, such as quality principles, regulatory compliance, documentation, validation, and biosafety levels. Through interactive seminars and practical exercises, students will gain a solid understanding of quality management systems, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). This course develops critical thinking skills for risk assessment, deviation management, and change control procedures. Upon completion, students will be equipped to apply quality assurance principles in biotechnology settings, understand biosafety regulations, and prepare necessary documentation for GMO authorization. This foundational knowledge is crucial for ensuring product quality, patient safety, and regulatory compliance in the biotechnology and pharmaceutical industries.

Lectures

Practices

Seminars

• 1. Introduction to Quality Assurance - Fittler András Tamás
• 2. Introduction to Quality Assurance - Fittler András Tamás
• 3. Infrastructural and personal background I. - Bóvári-Biri Judit
• 4. Infrastructural and personal background I. - Bóvári-Biri Judit
• 5. Infrastructural and personal background II. - Bóvári-Biri Judit
• 6. Infrastructural and personal background II. - Bóvári-Biri Judit
• 7. GMP vs GLP, and regulatory requirements - Fittler András Tamás
• 8. GMP vs GLP, and regulatory requirements - Fittler András Tamás
• 9. Working according to standards: Purpose and meaning of standard procedures - Fittler András Tamás
• 10. Working according to standards: Purpose and meaning of standard procedures - Fittler András Tamás
• 11. Managing deviations - Fittler András Tamás
• 12. Managing deviations - Fittler András Tamás
• 13. Quality metrics and key performance indicators - Fittler András Tamás
• 14. Quality metrics and key performance indicators - Fittler András Tamás
• 15. Quality management system, computerized system validation, data integrity  - Fittler András Tamás
• 16. Quality management system, computerized system validation, data integrity  - Fittler András Tamás
• 17. Change management and Quality Technical Agreements- - Fittler András Tamás
• 18. Change management and Quality Technical Agreements- - Fittler András Tamás
• 19. The role of qualification and validation in pharmaceutical quality assurance - Fittler András Tamás
• 20. The role of qualification and validation in pharmaceutical quality assurance - Fittler András Tamás
• 21. Audits and inspections in the pharmaceutical industry - Fittler András Tamás
• 22. Audits and inspections in the pharmaceutical industry - Fittler András Tamás
• 23. Authorization process to workwith Genetically Modified Organisms (GMO) - Nemes Balázs
• 24. Authorization process to workwith Genetically Modified Organisms (GMO) - Nemes Balázs
• 25. Biosafety levels and requirements - Somogyi Balázs Antal
• 26. Biosafety levels and requirements - Somogyi Balázs Antal
• 27. Risk assessment/Risk management  - Somogyi Balázs Antal
• 28. Risk assessment/Risk management  - Somogyi Balázs Antal

Reading material

Obligatory literature

Literature developed by the Department

List of study aids to acquire curriculum and all presentations can be downloaded from MS teams.

Notes

Recommended literature

Conditions for acceptance of the semester

Successful completion of the semester requires regular class attendance, completion of all assigned coursework, and taking the final test.

Mid-term exams

Assessment of the student performance is carried out according to a five-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/discussions, and course related project work must be completed.

Examiners

• Bóvári-Biri Judit
• Fittler András Tamás

Instructor / tutor of practices and seminars

• Bóvári-Biri Judit
• Fittler András Tamás
• Nemes Balázs
• Somogyi Balázs Antal