Information Package / Course Catalogue
Quality Control in Biotechnological Products
Course Code: MBTK645
Course Type: Area Elective
Couse Group: Third Cycle (Doctorate Degree)
Education Language: English
Work Placement: N/A
Theory: 3
Prt.: 0
Credit: 3
Lab: 0
ECTS: 8
Objectives of the Course

The aim of this course is to give ability to provide knowledge and skills about the standards and quality control processes required in the production of biotechnological products

Course Content

Production processes of biotechnological products, quality control stages, standards, certification stages, applications on authorized institutions will be explained.

Name of Lecturer(s)
Prof. Özge ÇEVİK
Learning Outcomes
1.To have knowledge about quality management system
2.Knowing and using quality control standards for biotechnological products
3.Learning and application of certification processes for biotechnological products
4.To be able to apply the standards for biotechnological products
5.Learning the legal processes on biotechnological productions
Recommended or Required Reading
1.All scientific journals and textbook on quality kontrol systems
Weekly Detailed Course Contents
Week 1 - Theoretical
Quality concept and components of Quality Control
Week 2 - Theoretical
Process management
Week 3 - Theoretical
Product control methods, analysis and data collection
Week 4 - Theoretical
Standards in biotechnological products
Week 5 - Theoretical
Pre-production standards in biotechnological products
Week 6 - Theoretical
Standards during production in biotechnological products
Week 7 - Theoretical
Post-production standards in biotechnological products-I
Week 8 - Theoretical
Post-production standards in biotechnological products-II (Midterm exam)
Week 9 - Theoretical
Accreditation, Calibration and EFQM model
Week 10 - Theoretical
Standards and organizations related to biotechnological products in Turkey
Week 11 - Theoretical
Standards and organizations related to Biotechnological Products in the World
Week 12 - Theoretical
Examination of ISO and TSE standards
Week 13 - Theoretical
Standards and sample application required in the production of biotechnological drugs
Week 14 - Theoretical
Required standards and sample application in the production of biotechnological diagnostic kit
Assessment Methods and Criteria
Type of AssessmentCountPercent
Midterm Examination1%30
Final Examination1%70
Workload Calculation
ActivitiesCountPreparationTimeTotal Work Load (hours)
Lecture - Theory140342
Assignment401560
Term Project20510
Laboratory20510
Reading130565
Quiz20510
Midterm Examination1033
Final Examination1033
TOTAL WORKLOAD (hours)203
Contribution of Learning Outcomes to Programme Outcomes
PÇ-1
PÇ-2
PÇ-3
PÇ-4
PÇ-5
PÇ-6
PÇ-7
PÇ-8
PÇ-9
PÇ-10
PÇ-11
PÇ-12
PÇ-13
OÇ-1
3
4
5
OÇ-2
3
4
5
OÇ-3
5
5
5
OÇ-4
3
3
4
4
OÇ-5
3
3
4
4
Adnan Menderes University - Information Package / Course Catalogue
2026