Quality Assurance in Pharmaceutical Industry

Data

Official data in SubjectManager for the following academic year: 2025-2026

Topic

Introduction to the quality assurance tasks of pharmaceutical manufacturing, with a detailed discussion of the “Good Manufacturing Practice” (GMP) guidelines. An overview of the possibilities and implementation of quality assurance in pharmacies.

Lectures

• 1. The development of pharmaceutical preparation - Pál Szilárd
• 2. The development of pharmaceutical preparation - Pál Szilárd
• 3. Quality, what is quality? General introduction. Quality assurance systems - Pál Szilárd
• 4. Quality, what is quality? General introduction. Quality assurance systems - Pál Szilárd
• 5. GMP, July 1, 2008 / Annex to Decree 44/2005 (X. 19.) of the Ministry of Health - Pál Szilárd
• 6. GMP, July 1, 2008 / Annex to Decree 44/2005 (X. 19.) of the Ministry of Health - Pál Szilárd
• 7. Pharmacy quality assurance - Pál Szilárd
• 8. Pharmacy quality assurance - Pál Szilárd
• 9. Personnel, organogram, conflicts of interest. Qualified Person (QP), key personnel - Pál Szilárd
• 10. Personnel, organogram, conflicts of interest. Qualified Person (QP), key personnel - Pál Szilárd
• 11. Facilities, connections, design requirements - Pál Szilárd
• 12. Facilities, connections, design requirements - Pál Szilárd
• 13. Cleanrooms / Aseptic work. Sterile preparations, parametric release - Pál Szilárd
• 14. Cleanrooms / Aseptic work. Sterile preparations, parametric release - Pál Szilárd
• 15. Manufacturing, pharmaceutical preparation / Batch records, laboratory logbooks / Raw materials, procurement, quality – expectations - Pál Szilárd
• 16. Manufacturing, pharmaceutical preparation / Batch records, laboratory logbooks / Raw materials, procurement, quality – expectations - Pál Szilárd
• 17. Equipment, instruments / Validation, qualification - Pál Szilárd
• 18. Equipment, instruments / Validation, qualification - Pál Szilárd
• 19. Documentation, training / New employees, continuous education / Departments, qualifications / QRM – Quality Risk Management - Pál Szilárd
• 20. Documentation, training / New employees, continuous education / Departments, qualifications / QRM – Quality Risk Management - Pál Szilárd
• 21. Contract manufacturing / Contract-based production; preparation. Pharmacy contracts. Inspection, Internal / Self-inspection, audit (checklist) - Pál Szilárd
• 22. Contract manufacturing / Contract-based production; preparation. Pharmacy contracts. Inspection, Internal / Self-inspection, audit (checklist) - Pál Szilárd
• 23. Prevention of drug mix-ups / Counterfeit medicines. Site Master File - Pál Szilárd
• 24. Prevention of drug mix-ups / Counterfeit medicines. Site Master File - Pál Szilárd
• 25. Quality Manual - Pál Szilárd
• 26. Quality Manual - Pál Szilárd
• 27. Mid-term assessment - Pál Szilárd
• 28. Mid-term assessment - Pál Szilárd

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

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Notes

Recommended literature

Conditions for acceptance of the semester

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Mid-term exams

The semester concludes with a written assessment. The assessment can be retaken or improved once.

Making up for missed classes

Fulfillment of the general requirements set out in the UP Faculty of Pharmacy's Code of Studies and Examinations. Students are required to attend classes, complete the prescribed practical sessions, and prepare reports on them. Any absences must be made up (individual make-up sessions are possible).

Exam topics/questions

Website of the Institute

Examiners

Instructor / tutor of practices and seminars

• Pál Szilárd