| Course Title | Code | Semester | L+U Hour | Credits | ECTS |
|---|---|---|---|---|---|
| - | ECZ505 | 9. Semester | 2 + 0 | 2.0 | 4.0 |
| Prerequisites | None |
| Language of Instruction | Turkish |
| Course Level | Undergraduate |
| Course Type | |
| Mode of delivery | Face to face |
| Course Coordinator |
Assist. Prof. Dr. Miray İLHAN |
| Instructors | |
| Assistants | |
| Goals | Giving basic information about Good Agricultural Practices (GAP) of medicinal plants, Giving basic information about Good Clinical Practices (GCP), Creating detailed information about Good Laboratory Practices (GLP), Laboratory, management, personnel, facility, equipment, process, Establishing the necessary infrastructure to ensure the robustness and validity of the analysis steps by informing the student about the organization of issues such as method validation, quality security and record keeping. Creating detailed information about good manufacturing practices (GMP), Understanding the importance and impact of good manufacturing practices in quality drug production by examining different GMP guides, Creating detailed information about good pharmacy practices (GPP). |
| Course Content | Definition and examination of GAP and GCP, Definition and examination of GLP, Distribution of duties and responsibilities, Rates (accounts) regarding the use of test and reference substances to be analyzed, Devices and materials, Physical and chemical test systems, Biological test systems, Testing and determining the properties of reference substances, sampling and storage, Standard study methods, Planning of the study and Result report and its content, Disposal of analytical wastes, Storage conditions of the samples to be analyzed, Drug analyzes according to pharmacopoeias, ISO 9001 quality management system, Definition and history of GMP, GMP guidelines applied in the world and their comparative examination, Safe, effective and quality drug definitions, Examination of safety effectiveness and quality information from the ICH guide, Examination of the GMP guide, Examination of quality guides and the concept of quality, GPP definition and examination of the guide. |
| Learning Outcomes |
- 1. Learns to keep the records necessary for the preparation and evaluation of the study report, which includes the findings of the original observations and activities in a study, and to examine them. - Learns to examine the quality guidelines. - Knows the ınternational standards for manufacturing of efficient, effective and qualified drug - Learns the international GMP guideline comparatively and informed of GMP applies in Türkiye - Knows the required GMP conditions at the authorization of drug and apply to the manufacturing facilities and control laboratories - Being capable of monitoring and evaluating the current developments in GMP - Knows the requirement of applying the GLP and GCP guidelines together with GMP and the importance of current monitoring |
| Week | Topics | Learning Methods |
|---|---|---|
| 1. Week | GAP, GLP, GCP, GMP and GPP overview and definitions | |
| 2. Week | Review of the GLP guideline | |
| 3. Week | Distribution of duties and responsibilities Rates (calculations) of the use of test and reference materials to be analyzed | |
| 4. Week | Devices and materials Physical, chemical and biological testing systems Determining the properties of test and reference materials for sampling and storage | |
| 5. Week | Standard operating methods Planning of the study and the final report and its content | |
| 6. Week | Drug analyzes according to pharmacopoeias ISO 9001 quality management system and Disposal of analytical waste | |
| 7. Week | Definition of GMP History of GMP GMP guideline applying in the world and investigation of them comparatively | |
| 8. Week | Midterm exam | |
| 9. Week | Definition of efficient, effective and qualified drug Investigation of the knowledge of efficiency, effectiveness and quality from ICH guidelines | |
| 10. Week | Examining the GMP guidelines | |
| 11. Week | Examining the GMP guidelines | |
| 12. Week | Examining the GMP guidelines | |
| 13. Week | Definition of GCP and investigation | |
| 14. Week | Definition of GPP and investigation | |
| 15. Week | Definition of GPP and investigation |
| Handbook of Good Laboratory Practice - World Health Organization Coursebook/Notes Good Manufacturing Practices for Pharmaceuticals, Sidney H. Willing, Marcel Dekker, 2001. Güncel ulusal ve uluslar arası yönetmelikler. Konuyla ilgili güncel makaleler Pharmaceutical Pre-Approval Inspections, guide to regulatory Success, 2 nd. Ed, Martin, D. Hyness, 2008. Process Validation in Manufacturing of Biopharmaceuticals, gudilines, current practices and Industrial case Studies., Anurag Singh Rathore, Gail Sofer.,2005. Validation of Pharmaceutical Processes, 3rd. Ed. James Agalloco, Frederick, J, Carleton, 2008. Other Resources United States Pharmacopeia (USP) European Pharmacopeia i (EP) British Pharmacopeia (BP) Martindale 35th Edition, 2007 Remington: The Science and Practice of Pharmacy 20th Edition, 2000. European Pharmacopoeia, 6th Edition, 2008. |
| Program Requirements | Contribution Level | DK1 | DK2 | DK3 | DK4 | DK5 | DK6 | DK7 | Measurement Method |
|---|
| 0 | 1 | 2 | 3 | 4 | 5 | |
|---|---|---|---|---|---|---|
| Course's Level of contribution | None | Very Low | Low | Fair | High | Very High |
| Method of assessment/evaluation | Written exam | Oral Exams | Assignment/Project | Laboratory work | Presentation/Seminar |
| Event | Quantity | Duration (Hour) | Total Workload (Hour) |
|---|---|---|---|
| Midterm 1 | 1 | 16 | 16 |
| Homework 1 | 1 | 15.5 | 15.5 |
| Final | 1 | 17 | 17 |
| Classroom Activities | 14 | 2 | 28 |
| Total Workload | 76.5 | ||
| ECTS Credit of the Course | 4.0 | ||
