• Türkçe
  • English
Course Code: 
PHAR 494
Course Period: 
Spring
Course Type: 
Core
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Objectives: 
This course aims to teach the students the essential components of Quality Management Systems, such as ISO -9000, ISO 1400, ISO 18000, principles of Pharmaceutical Quality Assurance and Good Manufacturing Practices (GMP). Development and worldwide harmonization of ICH Quality quidelines, details of Quality Assurance and GMP in pharmnaceutical industry is explained.
Course Content: 

Standards of ISO 9000, ISO 14000 and ISO 18000, development and implementation processes of  ICH Quality guidelines, EU and national standards, regulations and guidelines which are utilized in the pharmaceutical industry in the processes  used in the entire life-cycle of aproduct from  the early research to commercialisation and post marketing follow-up.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and true, E: Oral Exam F: Portfolio, G: Contribution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme learning outcomes

Teaching Methods

Assessment Methods

1) Explains the fundamentals of Quality Management System

1,2,3,4,5,8,12,13

1,2,3,4,6

A,B,C,D,H

2) Describes the content of ISO -9000, ISO 1400, ISO 18000 and GMP

1,2,3,12

1,2,3,4,6

A,B,C,D,H

3) Explains how ICH guidelines are developed.

1,2,3,12

1,2,3,4,6

A,B,C,D,H

4) Discusses the history and the necessity of  GMP

1,2,3,12

1,2,3,4,6

A,B,C,D,H

5) Explains  Eudralex Volume 4 (Good Manufacturing Practices) chapters (1 to 9) and annexes (1-20) and the Turkish GMP Guidelines.

1,2,3,12

1,2,3,4,6

A,B,C,D,H

6) Debates how these procedures and guidelines ensure product quality during the entire product lifecycle.

1,2,3,12

1,2,3,4,6

A,B,C,D,H

 

Course Flow

Week

Teorical Topics                                     

Lab content

Study Materials

1

Introduction to quality systems and definitions

 

 

2

Pharmaceutical Product Development and Life Cycle 

 

 

3

History and current  developments of GMP

 

 

4

Overview of  ICH Quality Guidelines and development process of guidelines

 

 

5

ICH Q8,ICH  Q9, ICH Q10 and ICH Q11

 

 

6

Introduction to Eudralex Volume 1 to 10,   Volume 4 Part I (GMP),  chapters 1-9 and Turkish GMP Guidelines.

 

 

7

Evaluation of all chapters of Volume 4 Part I in detail in order to understand details of GMP procedures, Chapters 1-9.

 

 

8

Evaluation of all chapters of Volume 4 Part I in detail in order to understand details of GMP procedures , Chapters 1-9.

 

 

9

Evaluation of all chapters of Volume 4 Part I in detail in order to understand details of GMP procedures, Chapters 1-9.

 

 

10

Evaluation of all chapters of Volume 4 Part I in detail in order to understand details of GMP procedures, Chapters 1-9.

 

 

11

Evaluation of Annexes 1-20

 

 

12

Evaluation of Annexes 1-20

 

 

13

Evaluation of Annexes 1-20

 

 

14

Guidelines on Good Distribution Practices of Medicinal products

 

 
 
 

Recommended Sources

Textbook

Lecture notes

Additional Resources

http://www.ich.org/

http:// ec.europa.eu/health/documents/eudralex/

http://www.iegm.gov.tr/Default.aspx?sayfa=kalite_sbmev&lang=tr-tr&thelaw...
 

 
 

Material Sharing

Documents

National and EU GMP Guidelines, A film by WHO about a GMP audit

Assignments

1 Homework

Exams

1 Midterm and  Final exam

 
 

Assessment

IN-TERM STUDIES

NUMBER

PERCENTAGE

Midterm  Exam I

1

60

Assignment-homework

1

40

   

 

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

50

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

50

Total

 

100

 

 

COURSE CATEGORY

Compulsary/Elective

 
 

Course’s Contribution to Program

No

Program Learning Outcomes

Contribution

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

   

X

   

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

   

X

   

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

   

X

   

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

   

X

   

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

   

X

   

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

         

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner .

         

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

   

X

   

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

         

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

         

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

         

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

       

X

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

     

X

 

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

         
 
 

ECTS

Activities

Quantity

Duration
(Hour)

Total
Workload
(Hour)

Course Duration (Including the exam week: 16x Total course hours)

16

2

31

Hours for off-the-classroom study (Pre-study, practice)

16

2,5

40

Midterm Exams

1

1

1

Lab. Applications

-

-

-

Hours for off-the-Lab. study (Pre-study, practice)

-

-

-

Lab. Midterm Exam

-

-

-

Lab. Final

-

-

-

Homework

1

5

5

Final

1

2

2

Total Work Load

 

 

79

Total Work Load / 25 (h)

 

 

3,16

ECTS Credit of the Course

 

 

3