Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
300005412015ANALYSIS METHOD DEVELOPMENT AND QUALITY CONTROL IN DRUG ANDUSTRYElective593
Level of Course Unit
First Cycle and Second Cycle
Language of Instruction
Objectives of the Course
With this course, it is aimed to have the equipment to develop analytical methods for analysis and quality control in the pharmaceutical industry.
Name of Lecturer(s)
Prof. Dr. M. Emrah KILINÇ, Prof. Dr. Özlem SÖĞÜT, Prof. Dr. K. Arzum ERDEM GÜRSAN, Prof. Dr. Pınar KARA KADAYIFCILAR, Doç Dr. Dilşat ARIKSOYSAL, , Doç. Dr. Hakan KARADENİZ
Learning Outcomes
1To have the competence to give information about Development of Analysis Method and Quality Control in Pharmaceutical Industry.
2To be able to comprehend and apply GLP- Good Laboratory Practices.
3To understand and apply high pressure liquid chromatography (HPLC) and Gas chromatography (GC) based separation methods.
4Being able to comprehend and apply Spectroscopic Methods based on absorption, emission and fluorescence.
5To be able to comprehend and apply electrochemistry.
6To be able to report analysis results, to apply method validity.
7To be able to comprehend and use the Laboratory Information Management System when necessary.
Mode of Delivery
Face to Face
Prerequisites and co-requisities
Recommended Optional Programme Components
General Chemistry I, II and Analytical Chemistry I, II courses are required to be successful.
Course Contents
Within the scope of the Development of Analysis Method in Pharmaceutical Industry and Quality Control course, GLP- Good Laboratory Practices, Separation Methods and related pharmaceutical analysis applications, HPLC applications, Separation Methods gas chromatography Application -GC, Spectroscopic Methods and applications, absorbance measurement, Spectroscopic Methods Application - Fluorescence, Information on Electrochemistry and Applications, Analysis Reporting Techniques, Method Validity, Validation, Laboratory Information Management System - LIMS will be given.
Weekly Detailed Course Contents
WeekTheoreticalPracticeLaboratory
1Development of Analysis Method in Pharmaceutical Industry and Quality Control-Introduction.
2GLP- Good Laboratory Practices
3Separation Methods
4Separation Methods Application -HPLC
5Separation Methods Application -GC
6Spectroscopic Methods
7Spectroscopic Methods Application - Absorbance measurement
8Spectroscopic Methods Application - Fluorescence measurement
9Midterm examination
10Electrochemistry and its Applications-I
11Electrochemistry and its Applications II
12Analysis Reporting Techniques
13Method Validity
14Laboratory Information Management System – LIMS
15Final Examination
Recommended or Required Reading
1. Douglas A. Skoog, Donald M. West, F. James Holler, Basics of Analytical Chemistry I and II, Translation editors Prof. Dr. Esma Kılıç, Prof. Dr. Fitnat Köseoğlu, Bilişim Yayıncılık, 7. Baskı, Ankara, 1999. 2. Daniel C Harris, Book of Analytical Chemistry, Translation Editors Prof. Dr. Güler Somer, Prof. Dr. Ali Osman Solak, Prof.Dr. Ali Rehber Türker, Prof. Dr. Esma Kılıç, Prof. Dr. Fitnat Köseoğlu, Prof. Dr.Latif Elçi, Prof. Dr.Mehmet Doğan, Prof. Dr.Mustafa Özcimder, Prof. Dr.Mustafa Özdemir, Prof. Dr.Serdar Ateş, Prof. Dr.Şeref Kunç, Prof. Dr.Şeref Güçer, Gazi Bureau Bookshop, Ankara, 1994. 3. Daniel C Harris, Quantitative Chemical Analysis, Translation Editor: Ali Rehber Türker, Palme Publishing, 2015, Ankara
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
Term (or Year) Learning ActivitiesQuantityWeight
SUM0
End Of Term (or Year) Learning ActivitiesQuantityWeight
SUM0
SUM0
Work Placement(s)
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination111
Final Examination11.51.5
Makeup Examination11.51.5
Attending Lectures50.31.5
Report Preparation155
Report Presentation11.51.5
Project Preparation166
Project Presentation11.51.5
Self Study5210
Individual Study for Mid term Examination5420
Individual Study for Final Examination7428
Homework212
TOTAL WORKLOAD (hours)79.5
Contribution of Learning Outcomes to Programme Outcomes
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LO1 2    3   5          
LO2 2    3   5          
LO3 2    3   5          
LO4 2    3   5          
LO5 2    3   5          
LO6 2    3   5          
LO7 2    3   5          
* Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High
 
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