GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
GOOD MANUFACTURING PRACTICES AND VALIDATION/FTE-2190
Course Title: GOOD MANUFACTURING PRACTICES AND VALIDATION
Credits 3 ECTS 8
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof.Dr.Füsun ACARTURK, Prof.Dr. Sevgi TAKKA
 -- WEB SITE(S) OF LECTURER(S)
   http://websitem.gazi.edu.tr/site/acarturk, http://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
Learning the total quality management and the concepts of quality assurance in drug
Learning the basic parameters(manufacturing, production areas, documentation, equipment and facilities, personel, records and reports
Teaching of quality control, validation (process, analytical methods) and analytical validation parameters
Learning the basic parameters of good laboratory practices (GLP)
Learning the guidelines and regulations on 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  Introduction to GMP / Applications in the world, definitions
2. Week  Facilities according to GMP, equipment and personnel according to GMP
3. Week  Manufacturing according to GMP
4. Week  Documentation (specifications, records, reports / SOPs, production / subcontracting)
5. Week  Packaging and labeling, good storage / good distribution practices
6. Week  Complaints and withdrawals / recovery, audit / self-audit
7. Week  Introduction to GLP / definition
8. Week  Pharmaceutical quality control / design of quality control laboratories
9. Week  Definition, purpose and content of validation, preparation of validation protocol and report
10. Week  Description of process validation and types (prospective and retrospective validation)
11. Week  Description of process validation and types (prospective and retrospective validation)
12. Week  Definition of process validation and types (revalidation and concurrent validation)
13. Week  Analytical method validation - theoric
14. Week  Analytical method validation - examples
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  -Good manufacturing Practices for Pharmaceuticals.S.H.Willing, Marcel Dekker, -Pharmaceutical Process Validation, R.A.Nash, A.H.Wachte New York, 2001 - Pharmaceutical Process Validation, R.A.Nash, A.H.Wachter, Marcel Dekker, New York, 2003
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration
 -- 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
3
30
 Designing and Applying Materials
10
2
20
 Preparing Reports
9
5
45
 Preparing Presentation
1
5
5
 Presentation
2
3
6
 Mid-Term and Studying for Mid-Term
1
4
4
 Final and Studying for Final
1
8
8
 Other
0
 TOTAL WORKLOAD: 
200
 TOTAL WORKLOAD / 25: 
8
 ECTS: 
8
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Posesses extensive knowledge accumulation on the field of Pharmaceutical Technology, learns pre-formulations of all pharmaceutical dosage forms, formulation designs and in vitro/in vivo evaluations of formulations.X
2Gains the capability of following up novalities in technology, and posesses the capability of literature search, evaluation and interpretation on the fields of Pharmacy.X
3Gains the capability of patent search and evaluation and patenting regarding the formulations of active drug ingredient, dosage forms and preparation technologies.X
4Learns sufficient knowledge on the the field of laboratory, pilot batch and industrial scale productions, quality controls, quality assurance system, good manufacture practice (GMP) and stability assurance of all dosage forms.X
5Learns the knowledge satisfying the capability level for designing original and generic drugs, evaluating process validation and quality assurance.X
6Learns the interpretation, statistical evaluation and practical application of the research results.X
7Posesses the knowledge on new drug delivery systems and posesses the knowledge and capacity on targetting these systems at a level of an expert.X
8Learns designing, formulations, preparation techniques, physical and chemical stabilities of biotechnological products.X
9Gains the capability of finding solutions to the problems encountered during research. He/she gains the capability of analytical thinking. He/she gains the capability of publishing the experimental results in the national/international journals.X
10Gains the capability of following and interpretion of important wold health organizations (FDA, EMA, ICH and WHO) and official reference books (pharmacopoeia etc.). As a result, he/she transfers his/her knowledge to the field of Pharmaceutical Technology, and develops new approaches.X