ECS536 Quality Control In Industrial Pharmacy

3 ECTS - 2-0 Duration (T+A)- 10. Semester- 2 National Credit

Information

Code ECS536
Name Quality Control In Industrial Pharmacy
Term 2023-2024 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

Update Time: 04.05.2023 12:59