GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PHARMACEUTICAL PRODUCTION PROCESSES AND TECHNOLOGIES/EE-1010
Course Title: PHARMACEUTICAL PRODUCTION PROCESSES AND TECHNOLOGIES
Credits 3 ECTS 9
Semester 2 Compulsory/Elective Compulsory
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Füsun Acartürk, Assoc.Prof. Fatmanur Tuğcu Demiröz, Assoc.Prof. Sibel İlbasmış Tamer
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/fatmanur, http://www.websitem.gazi.edu.tr/site/ilbasmis
 -- EMAIL(S) OF LECTURER(S)
  acarturk@gazi.edu.tr, nurtugcu@gmail.com,ilbasmis@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learn the basic production methods of pharmaceutical dosage forms
Learn the critical process parameters and steps on the production of pharmaceutical dosage forms
Have the ability to access, interpret and apply to guidelines
 -- 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  Manufacturing process of liquid dosage forms. Mixing, solubilizing, manufacturing, effective parameters, and critical process steps
2. Week  Manufacturing process of semi-solid dosage forms. Ointments, creams, gels, effective parameters
3. Week  Manufacturing of solid dosage forms. The effect mixing and milling of powders on tablet production, critical process steps
4. Week  Coating of powders and granules. Pellet technology
5. Week  Oral tablet formulations
6. Week  Compaction of tablets, the effects of tablet pressing machines on the properties of tablets,
7. Week  The production of coated and modify released tablets, effective parameters, critical process steps
8. Week  Capsules, hard gelatin/cellulose capsules
9. Week  The production of capsules, effective parameters, critical process steps
10. Week  Soft gelatin capsules and manufacturing processes, effective parameters, critical process steps
11. Week  Aseptic processes, laminar air flow cabins,aseptic conditions and sterile production
12. Week  Sterile drug manufacturing Validation of filtration and sterile production, effective parameters, critical process steps
13. Week  Regulations and requirements releated with pharmaceutical manufacturing processes
14. Week  Special technologies Biotechology Radiopharmaceuticals
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  Acarturk, F, Agabeyoglu, i, Çelebi n, Değim T, Değim Z, Doğanay, T, Takka S, Tırnaksız F, Modern Farmasötik Teknoloji, Türk Eczacıları Birliği Publication
 -- 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
10
4
40
 Searching in Internet and Library
10
5
50
 Designing and Applying Materials
10
1
10
 Preparing Reports
10
4
40
 Preparing Presentation
5
3
15
 Presentation
2
4
8
 Mid-Term and Studying for Mid-Term
1
8
8
 Final and Studying for Final
1
12
12
 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