TÜRKÇE
ENGLISH
Information
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
Resources
Notes
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 | - | Have sufficient knowledge in pharmaceutical field and develop the knowledge gained. | 4 |
| PLO02 | - | Applies the profession in accordance with the existing laws and regulations,gains awareness of professional and ethical responsibility. | 4 |
| PLO03 | - | It serves the society as a pharmacist who is loyal to Atatürk's principles and reforms, equipped with Universal Knowledge, who uses Turkish correctly and knows at least one foreign language. | 5 |
| PLO04 | - | Communicates effectively both orally and in writing. | 4 |
| PLO05 | - | External appearance, attitude, attitude and behavior, with professional identity, role model and society becomes an example to colleagues. | 4 |
| PLO06 | - | Provides consultancy services to patients, community and health care personnel with a wide range of information on the drug,evaluates advanced knowledge and skills with a critical approach. | 5 |
| PLO07 | - | 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 |
| PLO08 | - | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | 5 |
| PLO09 | - | Interprets information about current health and treatment problems. Plays an active role in community health. | 4 |
| PLO10 | - | Pharmacy integrates and develops professional knowledge with information from different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | 5 |
| PLO11 | - | Students will be able to use the concepts and applications of basic sciences and basic medical sciences effectively in the field of Medicine and pharmacy and have the experience of working with these health sciences. | 4 |
| PLO12 | - | Acquires basic information about diseases, adopts and applies rational drug use on all drugs that affect systems. | 5 |
| PLO13 | - | By learning the basics of Clinical Pharmacy,will have the knowledge and skills to help provide drug/patient oriented pharmacy applications and individualized Pharmaceutical Care. | 4 |
| PLO14 | - | It plays a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | 4 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | The importance of quality control in drug production | Books and scientific databases | |
| 2 | Quality control methods in pharmaceutical production | Books and scientific databases | |
| 3 | Quality management and quality assurance in the pharmaceutical industry | Books and scientific databases | |
| 4 | GMP: Good manufacturing practices | Books and scientific databases | |
| 5 | GLP: Good laboratory practices | Books and scientific databases | |
| 6 | Patents, data protection and intellectual property rights | Books and scientific databases | |
| 7 | Patents, data protection and intellectual property rights | Books and scientific databases | |
| 8 | Mid-Term Exam | ||
| 9 | Pharmacopoeia analysis | Books and scientific databases | |
| 10 | Pharmacopoeia analysis | Books and scientific databases | |
| 11 | Analytical methods and techniques in quality control | Books and scientific databases | |
| 12 | Classical methods | Books and scientific databases | |
| 13 | , Chromatographic techniques, Spectroscopic methods, | Books and scientific databases | |
| 14 | Combined analytical techniques, İmpurity determining methods in drugs | Books and scientific databases | |
| 15 | Analytical method validation parameters | Books and scientific databases | |
| 16 | Term Exams | ||
| 17 | Term Exams |
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 | ||