TÜRKÇE
ENGLISH
Information
| Code | ECS536 |
| Name | Quality Control In Industrial Pharmacy |
| Term | 2022-2023 Academic Year |
| Semester | 10. Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 3 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Prof. Dr. Hacı Ali DÖNDAŞ |
| Course Instructor |
Prof. Dr. Hacı Ali DÖNDAŞ
(A Group)
(Ins. in Charge)
|
Course Goal / Objective
The scope of this course is to teach the principles, regulations and analysis techniques in the production of high quality drugs
Course Content
The importance of quality control in drug production, Quality control methods in pharmaceutical production, Quality management and quality assurance in the pharmaceutical industry, GMP: Good manufacturing practices, GLP: Good laboratory practices, Patents, data protection and intellectual property rights, Pharmacopoeia analysis, Analytical methods and techniques in quality control; Classical methods , Chromatographic techniques, Spectroscopic methods, Combined analytical techniques, İmpurity determining methods in drugs, Analytical method validation parameters
Course Precondition
not required
Resources
A.H. Beckett, J.B. Stenlake, Practical Pharmaceutical Chemistry, 1988, The Athlone Press, Fourth Edition-Part One, London E. İzgü, İlaç Sanayiinde Milli Ve Milletlerarası Kanunlar, Anlaşmalar, Yönetmelikler Yönünden İyi İmalat (GMP) Ve Kontrol (GLP) Uygulama Kuralları Ankara Üniversitesi Eczacılık Fakültesi Yayınları 61 Ankara 1988.
Notes
Lecture presentations and internet
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | To understand the importance of quality control in drug production |
| LO02 | To learn about quality management and quality assurance in the pharmaceutical industry |
| LO03 | To know good manufacturing practices and good laboratory practices |
| LO04 | To know and apply the analytical techniques and methods in quality control determination |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Have sufficient knowledge in pharmaceutical field and develop the knowledge. | 5 |
| PLO02 | Bilgi - Kuramsal, Olgusal | Comprehends professional knowledge with ethical responsibility through current laws and legislation. | |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Provides consultancy service to patients, community and health care personnel and evaluates advanced knowledge and skills with a critical approach. | |
| PLO04 | Beceriler - Bilişsel, Uygulamalı | Possessing the knowledge of historical and current developments in the field of Pharmacy, monitoring, evaluation and application of scientific and evidence-based data, and adopting lifelong learning. | 4 |
| PLO05 | Beceriler - Bilişsel, Uygulamalı | Have the knowledge and skills to help provide patient-oriented pharmacy applications and individualized pharmaceutical care by learning the basics of Clinical Pharmacy, | |
| PLO06 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Takes a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | |
| PLO07 | Yetkinlikler - Öğrenme Yetkinliği | Integrates and develops professional knowledge via different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | |
| PLO08 | Yetkinlikler - Öğrenme Yetkinliği | Use effectively the concepts and applications of basic sciences and basic medical sciences in the field of medicine and pharmacy and update the information. | |
| PLO09 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Communicates effectively in writing and speaking. | |
| PLO10 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Practices the profession in accordance with Atatürk's principles and reforms, equipped with universal knowledge, uses Turkish correctly and knows at least one foreign language. | |
| PLO11 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Be an example to society withexternal appearance, demeanor, attitude and behavior for the other professionals and society and with professional identity | |
| PLO12 | Yetkinlikler - Alana Özgü Yetkinlik | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | |
| PLO13 | Yetkinlikler - Alana Özgü Yetkinlik | Interprets information about current health and treatment problems and attends meeting on related matters . Plays an active role in community health. | 3 |
| PLO14 | Yetkinlikler - Alana Özgü Yetkinlik | Acquires basic information about diseases, makes decisions about the drugs used in treatment in accordance with rational drug use. | 4 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | The importance of quality control in drug production | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | Quality control methods in pharmaceutical production | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Quality management and quality assurance in the pharmaceutical industry | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | GMP: Good manufacturing practices | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | GLP: Good laboratory practices | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | Patents, data protection and intellectual property rights 1 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | Patents, data protection and intellectual property rights 2 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav |
|
| 9 | Pharmacopoeia analysis 1 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Pharmacopoeia analysis 2 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Analytical methods and techniques in quality control | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | Classical methods | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Chromatographic techniques, Spectroscopic methods, | Books and scientific databases | Öğretim Yöntemleri: Soru-Cevap, Tartışma |
| 14 | Combined analytical techniques, İmpurity determining methods in drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Analytical method validation parameters | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav |
|
| 17 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 2 | 28 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 6 | 6 |
| Final Exam | 1 | 16 | 16 |
| Total Workload (Hour) | 78 | ||
| Total Workload / 25 (h) | 3,12 | ||
| ECTS | 3 ECTS | ||