GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PROCESS ANALYTICAL TECHNOLOGY(PAT) -QUALITY BY DESIGN(QBD)/EE-1070
Course Title: PROCESS ANALYTICAL TECHNOLOGY(PAT) -QUALITY BY DESIGN(QBD)
Credits 2 ECTS 7
Semester 2 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
   Prof. Dr. Sevgi Takka, Prof.Dr. Füsun Acartürk
 -- WEB SITE(S) OF LECTURER(S)
  http://www.websitem.gazi.edu.tr/site/takka, http://www.websitem.gazi.edu.tr/site/acarturk
 -- EMAIL(S) OF LECTURER(S)
  takka@gazi.edu.tr, acarturk@gazi.edu.tr,
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Possesses the knowledge about the design and development of formulation and manufacturing process to enhance product quality
Learns the follow up and control the manufacturing process and specify the critical process steps for manufacturing
Learns to improve the manufacturing process with the changes made
Learns how to apply PAT and QbD applications for the targeted quality at the end of the process and to ensure the continuity of 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  Describe of manufacturing process, critical parameters of production for solid dosage forms
2. Week  Describe of manufacturing process, critical parameters of production for liquid dosage forms
3. Week  Describe of manufacturing process, critical parameters of production for semi-solid dosage forms
4. Week  PAT implementation in planning and optimizing of production
5. Week  Mathematical characterization of production process, statistically assessment of multivariate tools, to ensure optimization of process
6. Week  PAT for quality control laboratory operations
7. Week  Quality by Design
8. Week  Quality by Design for the generic drugs
9. Week  Quality by Design for the modified release drugs
10. Week  Efficiency in manufacturing and relationship between economy and PAT
11. Week  PAT and risk management, risk assessment (qualitative and quantitative approaches)
12. Week  Regulations and PAT
13. Week  PAT applications in-process control, in-line applications
14. Week  Application of PAT in pharmaceutical industry (Near-Infrared spectroscopy – Theory and analyse technology )
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  1.Process Analytical Technology, Edt: K.A.Bakeev, Blackwell Pub.,2005. 2.Guidance for Industry , PAT – A Framework for innovative pharmaceutica
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  NA
 -- 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
2
28
 Practising Hours of Course Per Week
0
 Reading
11
5
55
 Searching in Internet and Library
9
4
36
 Designing and Applying Materials
0
 Preparing Reports
6
3
18
 Preparing Presentation
3
4
12
 Presentation
4
2
8
 Mid-Term and Studying for Mid-Term
1
8
8
 Final and Studying for Final
1
10
10
 Other
0
 TOTAL WORKLOAD: 
175
 TOTAL WORKLOAD / 25: 
7
 ECTS: 
7
 -- 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