GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
QUALITY MANAGEMENTIN DRUG PRODUCTION/EE-1020
Course Title: QUALITY MANAGEMENTIN DRUG PRODUCTION
Credits 3 ECTS 9
Semester 2 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Füsun Acartürk, Prof. Sevgi Takka
 -- WEB SITE(S) OF LECTURER(S)
  http://www.websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/takka
 -- EMAIL(S) OF LECTURER(S)
  acarturk@gazi.edu.tr,takka@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learn the efficient, reliable and high quality pharmaceutical manufacturing rules
Learn the concepts of total quality management and drug quality assurance
Learn the basic parameters of good manufacturing practice (GMP)
Learn the basic parameters of good labratory practice (GLP)
Learn the basic concepts and parameters releated with validation(process, analytical method)
Learn the official quidelines and regulations releated with drug quality
 -- MODE OF DELIVERY
  The mode of delivery of this course is face to face
 -- PREREQUISITES AND CO-REQUISITES
  There is no prerequisite or co-requisite for this course.
 -- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS
  There is no recommended optional programme component for this course
 --COURSE CONTENT
1. Week  Quality assurance and organization
2. Week  GMP in drug production
3. Week  Quality control and GLP
4. Week  Definition and classification of validation
5. Week  Process validation
6. Week  Sampling in starting and packaging materials
7. Week  Self-inspection and quality audits carried out by health authority
8. Week  Quality assurance in sterile products
9. Week  Quality assurance in biotech products
10. Week  Quality assurance in the production of inhalation products
11. Week  Barcode tracking systems and related softwares
12. Week  GMP regulations in the computer systems
13. Week  Contract production, licensed production, co-marketing requirements
14. Week  Quality control and parametric tests
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  -Pharmaceutical Process Validation, Robert A. Nash, Alfred H. Wachter, An International Third Edition, Revised andExpanded, 1993. -Good Manufacturin
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  Not Applicable
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
0
0
 Assignment
1
10
 Exercises
0
0
 Projects
1
30
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
40
 Contribution of Final Examination to Overall Grade  
60
 -- WORKLOAD
 Efficiency  Total Week Count  Weekly Duration (in hour)  Total Workload in Semester
 Theoretical Study Hours of Course Per Week
14
3
42
 Practising Hours of Course Per Week
0
 Reading
7
4
28
 Searching in Internet and Library
7
6
42
 Designing and Applying Materials
7
3
21
 Preparing Reports
7
5
35
 Preparing Presentation
5
6
30
 Presentation
4
3
12
 Mid-Term and Studying for Mid-Term
1
5
5
 Final and Studying for Final
1
10
10
 Other
0
 TOTAL WORKLOAD: 
225
 TOTAL WORKLOAD / 25: 
9
 ECTS: 
9
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Follow the development as having the knowledge and skills in the field of industrial pharmacy, transfer the information to the pharmaceutical industry and develop new approaches in this area.X
2Gains the ability to acess and apply to the health orginazations guidlines such as FDA, EMA, WHO.X
3Preparation and evaluation of the CTD format of the license application to the Turkish Drug and Medical Devices Agency and learn the types of license application made to the other health organizationsX
4Posess the knowledge on the total quality management, GMP, GLP, GSP, QA / QC, process validation, analytical validation and qualification in in the pharmaceutical industry.X
5Learns the concept of systematic R&D, techniques, tools and scale up in drug development.X
6Learns the concept and application of drug formulation development by using quality by design (QbD) and process analytical technology (PAT).X
7Posseses the ability to evaluate and interprete the drug patent databases (TPE, EPO, WIPO etc.)X
8Learns the concept of original and generic drug and the evaluation and interpretation of the study design of bioavalability/bioequivalanceX
9Posess the knowledge and skill about the analytical techniques, method development and validation in the industrial pharmacy.X
10Get the application skill in the releated area by pursuing knowledge in the field of pharmacovigilance and pharmacoeconomics.X
11Develops new approaches to potential problems and bring solutions by using the knowledge in the releated area.X