Quality Assurance in Pharmaceutical Industry

Daten

Offizielle Daten in der Fachveröffentlichung für das folgende akademische Jahr: 2025-2026

Thematik

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.

Vorlesungen

• 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

Praktika

Seminare

Materialien zum Aneignen des Lehrstoffes

Obligatorische Literatur

Vom Institut veröffentlichter Lehrstoff

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Skript

Empfohlene Literatur

Voraussetzung zum Absolvieren des Semesters

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Semesteranforderungen

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

Möglichkeiten zur Nachholung der Fehlzeiten

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).

Prüfungsfragen

Website of the Institute

Prüfer

Praktika, Seminarleiter/innen

• Pál Szilárd