1) 1. What is GMP? What is the target of GMP What are the parts of the GMP guideline? 2) 2. List and characterize the basic principles of GMP. 3) 3. Describe the elements of the QbD approach. 4) 4. What is the purpose of the control strategy in the QbD approach? 5) 5. Who are the key people in pharmaceutical manufacturing? What are their individual and common responsibilities? 6) 6. Why is personnel training important in pharmaceutical manufacturing? Training topics. 7) 7. What principles apply to GMP premises (design, location, layout, etc.)? 8) 8. What areas are there in the pharmaceutical factory, describe them? 9) 9. What are the requirements for equipment used in production? 10) 10. What is the purpose of the documentation during production? What types of documentation (two primary types) are used to manage and record GMP compliance? 11) 11. List and characterize the types of instructions from the documentation. 12) 12. List and characterize the types of reports from the documentation. 13) 13. What are the general instructions for production? 14) 14. Speak about of Quality Risk Management process in case of products manufactured. 15) 15. What is the role of quality control in a pharmaceutical company? What is the function of the Quality Control Department? 16) 16. How is the sampling done (starting material, final product)? 17) 17. Why are there outsourced activities in pharmaceutical companies? How is outsourcing done? 18) 18. Speak about investigation of complaints and quality defects and product recalls. 19) 19. List and characterize the types of GMP inspection. 20) 20. Production of Herbal Medicinal Products (premises, production, quality control, documentation) 21) 21. Manufacture of Active Pharmaceutical Ingredient/API. Where does the production of a “Active Pharmaceutical Ingredient” start - from a GMP point of view? 22) 22. What is a Investigational Medicinal Product/IMP? Production of Investigational Medicinal Product/IMP (personel, premises, production, quality control, documentation). 23) 23. GMP principles for the production of sterile products (workspace, air supply, personnel, equipment). 24) 24. GMP monitoring of facilities for the production of sterile products. 25) 25. What are the differences required by GMP between the production of terminally sterilizable and aseptically prepared sterile pharmaceuticals? 26) 26. What is Validation? What needs validation? List the types of validation and present them! 27) 27. What is the difference between qualification and validation? What are qualification types? 28) 28. Describe the steps and aim of bioprocessing of biologics. 29) 29. Describe the structure and production possibilities of monoclonal antibodies. 30) 30. Describe the possibilities of vaccine production, classify the types of vaccines. 31) 31. Describe the challenges of oral administration of macromolecules (biopharmaceuticals, formulation aspects, delivery devices)! 32) 32. Describe the challenges of pulmonary delivery of macromolecules (biopharmaceuticals, formulation aspects, delivery devices)! 33) 33. Describe the challenges of nasal administration of macromolecules (biopharmaceuticals, formulation aspects, delivery devices)! 34) 34. What considerations should be considered when choosing a carrier system and manufacturing process for the alternative administration of biopharmaceuticals? 35) 35. What is the PAT? List the benefits of PAT-based manufacturing! PAT in the production of solid dosage forms. 36) 36. What is the tissue origin of the Caco-2 cell line, which biological barrier is modelled by this cell line, and what are the characteristics of the barrier tightness? 37) 37. What does it mean if a high apparent permeability coefficient is measured across a barrier model, which mechanism can be responsible for it? Please give examples for molecules with high penetration across biological barriers. 38) 38. Please describe what are the three main cell types forming the blood-brain barrier and the major mechanisms blocking drug entry to the brain at the level of brain endothelial cells? 39) 39. Biopharmaceutical aspects of paediatrics (pharmacokinetic properties) 40) 40. Paediatric formulations and additives 41) 41. Biopharmaceutical aspects of geriatrics (pharmacokinetic properties) 42) 42. Geriatric formulations and additives

Questions A - Pharmaceutical technology 4. (lecture)

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