Tantargy

Adatok

A Tantárgybejelentőben megadott hivatalos adatok az alábbi tanévre: 2025-2026

Tematika

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.

Előadások

• 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

Gyakorlatok

Szemináriumok

A tananyag elsajátításához szükséges segédanyagok

Kötelező irodalom

Saját oktatási anyag

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Jegyzet

Ajánlott irodalom

A félév elfogadásának feltételei

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Félévközi ellenőrzések

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

Távolmaradás pótlásának lehetőségei

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).

Vizsgakérdések

Website of the Institute

Vizsgáztatók

Gyakorlatok, szemináriumok oktatói

• Pál Szilárd