| Course Type | Elective Course |
|---|
| Course Level | Bachelor's Degree |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 2 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learns the requirements of pharmaceutical production according to GMP by examining the relevant guides.
- Have information about the principles of contract manufacturing.
- Learns the withdrawal rules of drugs.
- Have information about process validation and types.
- Transfer the knowledge and skills gained on GMP and quality assurance to the pharmaceutical industry.
- Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life.
- Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | It covers basic concepts related to quality management, quality assurance, good manufacturing practices (GMP) in industrial production, related guidelenes and regulations. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Quality assurance, definition and importance |
|
2nd Week |
Quality assurance, GMP, cGMP GLP, ISO concepts, international (FDA, EMEA, WHO, ICH, PIC) quality assurance practise |
|
3rd Week |
Basic concepts and definitions in GMP |
|
4th Week |
Introduction and examine of the GMP guideline of TITCK |
|
5th Week |
Requirements according to GMP in pharmaceutical production - production plant |
|
6th Week |
Requirements according to GMP in pharmaceutical production - equipment-personnel |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Requirements according to GMP-Manufacturing-contract manufacturing |
|
9th Week |
Requirements according to GMP - Documentation (Records) ? Standart Operation Procedure (SOP) |
|
10th Week |
Complaints - Withdrawal |
|
11th Week |
Packaging materials - good storage and distribution practices |
|
12th Week |
Process validation and types (prospective, retrospective validation) |
|
13th Week |
Process validation and types (revalidation and concurrent validation) |
|
14th Week |
Good laboratory practices (GLP) and establishment of a laboratory according to GLP |
|
| 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 |
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
40 |
| Total(%) |
|
40 |
| Contribution of In-term Studies to Overall Grade(%) |
|
40 |
| Contribution of Final Examination to Overall Grade(%) |
|
60 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
1 |
14 |
| Preparation for Final exam |
1 |
8 |
8 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
6 |
6 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
1 |
5 |
5 |
| Total Work Load | 65 |
| Total Work Load / 30 (h) | 2.16 |
| ECTS Credit of the Course | 2 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
