| Course Type | Elective Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 5 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learns the principles of quality assurance and GMP practices in the production of quality, effective and safe pharmaceuticals.
- Gains knowledge of the principles of licensed, contract and co-marketing products.
- Knows good laboratory practices, quality control tests and parametric tests
- Gains knowledge of process validation and types.
- Learns the guides published by national and international authorities on GMP.
- Use the acquired knowledge and skills in pharmaceutical industry and other institutions.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | It includes basic concepts related to quality management, quality assurance, good manufacturing practices (GMP) in industrial production, related guides and regulations. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Quality assurance, definition, importance and organization |
|
2nd Week |
Quality assurance, GMP, cGMP, GLP, ISO concepts, international quality assurance practices (FDA, EMA, WHO, ICH, PIC,) |
|
3rd Week |
Basic concepts and definitions in GMP, GMP guide published by TITCK |
|
4th Week |
Requirements according to GMP in pharmaceutical production - Production plant |
|
5th Week |
Requirements in pharmaceutical production according to GMP Production, licensed, contract and co-marketing products. |
|
6th Week |
Requirements according to GMP in pharmaceutical production - equipment-personnel |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Requirements according to GMP - Documentation (Records) ? Standart Operation Procedure (SOP) |
|
9th Week |
Requirements according to GMP - Documentation (Records) ? Standart Operation Procedure (SOP) |
|
10th Week |
Complaints ? Withdrawal, Packaging materials - good storage and distribution practices |
|
11th Week |
Process validation and types (prospective, retrospective validation) |
|
12th Week |
Quality assurance and GMP practices in the production of inhaled products |
|
13th Week |
Quality assurance and GMP applications in biotechnological products |
|
14th Week |
Good laboratory practice (GLP) and quality control tests, parametric tests |
|
| Recommended or Required Reading | 1. Lecturer notes
2. GMP Guideline (TİTCK-2018)
3. Good Manufacturing Practices for Pharmaceuticals Edited by Joseph D. Nally, 2007, Taylor and Francis group, CRC Press, ISBN: 134:978-1-4200-2093-9 (e book)
|
|---|
| Planned Learning Activities and Teaching Methods |
- Teorik
- interaktif anlatım
- tartışma
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
30 |
| Assignment |
2 |
20 |
| Total(%) |
|
50 |
| Contribution of In-term Studies to Overall Grade(%) |
|
50 |
| Contribution of Final Examination to Overall Grade(%) |
|
50 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
0 |
0 |
0 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
2 |
28 |
| Preparation for Final exam |
1 |
14 |
14 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
0 |
0 |
0 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
3 |
3 |
| Homework |
2 |
12 |
24 |
| Presentation (including preperation) |
1 |
14 |
14 |
| Literature review |
12 |
3 |
36 |
| Total Work Load | 147 |
| Total Work Load / 30 (h) | 4.9 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
