GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
QUALITY SYSTEMS IN ANALYTICAL LABORATORIES IN PHARMACEUTICAL INDUSTRY/ECZ 5609
Course Title: QUALITY SYSTEMS IN ANALYTICAL LABORATORIES IN PHARMACEUTICAL INDUSTRY
Credits 2 ECTS 4
Course Semester 9 Type of The Course Elective
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
Test laboratorymanagementandresponsibilities of staff,
Quality assurance program and audit
Knowledge of the responsibilities of the quality assurance staff
Knowledge of Standard Operating Instructions
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 -- MODE OF DELIVERY
  The mode of delivery of this course is Face to face
 --WEEKLY SCHEDULE
1. Week  Rules and quality standards
2. Week  Quality Management System ISO-9001/2000- Principles Applications, Organization, Personnel Authorities and Responsibilities
3. Week  OECD Good Laboratory Practices (OECD-GLP)- History and Necessity
4. Week  OECD Good Laboratory Practices (OECD-GLP)- Organization
5. Week  OECD Good Laboratory Practices (OECD-GLP)- Standard Operating Instructions
6. Week  OECD Good Laboratory Practices (OECD-GLP)- Staff Assignments
7. Week  OECD Good Laboratory Practices (OECD-GLP)- Supervision
8. Week  Midterm Exam
9. Week  ISO-17025 Test and Calibration Qualification Requirements- History and Necessity, Application
10. Week  ISO-17025 Test and Calibration Qualification Requirements- Accreditation Institutions, Similarities and Differences with GLP
11. Week  ISO-17025 Test and Calibration Qualification Requirements- Laboratory Proficiency Tests
12. Week   Environmental Management System (ISO-14001)- Organization
13. Week  Environmental Management System (ISO-14001)- Standard Operating Instructions, Application and Inspection
14. Week  Occupational Health and Safety Management System (OHSAS 18001)- Organization, Standard Operating Instructions, Implementation and Supervision
15. Week  Medical Devices Quality Management System (ISO-13485)
16. Week   Final Exam
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
60
 Assignment
1
40
 Application
0
0
 Projects
0
0
 Practice
0
0
 Quiz
0
0
 Percent of In-term Studies  
50
 Percentage of Final Exam to Total Score  
50
 -- WORKLOAD
 Activity  Total Number of Weeks  Duration (weekly hour)  Total Period Work Load
 Weekly Theoretical Course Hours
14
3
42
 Weekly Tutorial Hours
0
0
0
 Reading Tasks
5
2
10
 Searching in Internet and Library
5
1
5
 Material Design and Implementation
0
0
0
 Report Preparing
0
0
0
 Preparing a Presentation
5
3
15
 Presentation
1
5
5
 Midterm Exam and Preperation for Midterm Exam
1
12
12
 Final Exam and Preperation for Final Exam
1
12
12
 Other (should be emphasized)
0
0
0
 TOTAL WORKLOAD: 
101
 TOTAL WORKLOAD / 25: 
4.04
 Course Credit (ECTS): 
4
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Completing Bachelor Degree in Pharmacy, the Bachelor of Science graduate is able to apply his/her gained knowledge and skills to all of the fields of Pharmacy profession within the framework of law, regulations, principles, professional values and ethical rules.X
2Combining with the applications regarding Pharmacy profession, he/she is able to use the concepts and applications of fundamental science, medicine and health sciences in the field of pharmacy.X
3He/she knows the anatomy, immunology, physiology, physiopathology and biochemistry of biological systems. He/she knows the diseases affecting human health and fundamental concepts of therapy.X
4He/she has the sufficient knowledge to fulfill and assess the physical, chemical, toxicological, biological, microscopic, microbiological, molecular and elemental analysis of herbal drugs, biological and enviromental reference materials, food, food additives and contaminants, drug, active ingredient and excipients and medical products using scientific resources, pharmacopeis and validated methods.X
5He/she has knowledge and application capability on pre-formulation, formulation, laboratory, pilot batch and industrial scale productions, quality assurance, stability, storage, bioavailability, bioequivalance, drug authorization and patent studies of pharmaceutical products containing natural or synthetic active drug ingredient, biotechnological, nanotechnological, cosmetic, dermacosmetic and radiopharmaceutical products.X
6He/she possesses knowledge and application capability on recognition of drug targets, chemical structures, synthesis and analysis, effects, structure-activity relationships, design, development and determination of therapeutic dose of active drug ingredients with the knowledge on toxicological, pharmacokinetic and pharmacodynamic properties and side effects.X
7He/she has sufficient knowledge on magisterial preparations, usage and regulations of all original and generic drug products and medical products.X
8He/she has knowledge regarding the effects of drugs on biochemical parameters, drug-drug, food-drug, disease-drug interactions, following and preventing adverse drug effects, and pharmacovigilance.X
9He/she possesses knowledge and application capability on the subjects regarding pharmaceutics, phytopharmaceutics, biopharmaceutics, pharmaceutical care, pharmacotherapy, cosmetology, and clinical pharmacy.X
10He/she possesses the capability of giving and representing the prescribed drugs to the patient, assessing the clinical laboratory results, giving useful and practical information regarding the products such as dietary supplements, nutraceutics, health and diseases within the framework of rational drug use.X
11He/she identifies the medicinal and poisonous plants morphologically and by microscope. He/she has detailed knowledge on the secondary ingredient groups that present in medicinal plants.X
12He/she knows the effects of drugs and other chemical substances and biological and physical factors on the biological systems and enviroment, and toxicological risk assessment process. He/she possesses knowledge on the subjects regarding toxicity prevention and treatment approaches.X
13He/she possesses knowledge on the subjects regarding politics and economics of health intended to enhance public health and quality of life, drug, medical device, drug reimbursement and pharmacy management.X
14He/she is able to follow up national/international historical and up-to-date developments in the field of Pharmacy using technological tools, data base and source of information, assess data based on science and evidence, and adopt lifelong learning.X
15He/she is able to communicate effectively with the other professional groups and societies such as health legal authorithy, drug industry and professional organizations about the subjects regarding health, he/she is able to bring solutions and make suggestions for the problems regarding the professional field.X
16He/she possesses foreign language skill at a level to be able to communicate with the pofessional colleagues and patients for the profession of pharmacy.X
 -- NAME OF LECTURER(S)
   ( Prof. Dr. Tijen ÖNKOL , Doç. Dr. Murat Kadir ŞÜKÜROĞLU )
 -- WEB SITE(S) OF LECTURER(S)
   ( http://websitem.gazi.edu.tr/site/tijen , http://websitem.gazi.edu.tr/site/mkadir)
 -- EMAIL(S) OF LECTURER(S)
   ( tijen@gazi.edu.tr , mksukuroglu@gmail.com)