At the end of this course, the students; 1) Learns the requirements of pharmaceutical production according to GMP by examining the relevant guides. 2) Have information about the principles of contract manufacturing. 3) Learns the withdrawal rules of drugs. 4) Have information about process validation and types. 5) Transfer the knowledge and skills gained on GMP and quality assurance to the pharmaceutical industry. 6) Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life. 7) Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
None
COURSE DEFINITION
It covers basic concepts related to quality management, quality assurance, good manufacturing practices (GMP) in industrial production, related guidelenes and regulations.
COURSE CONTENTS
WEEK
TOPICS
1st Week
Quality assurance, definition and importance
2nd Week
Quality assurance, GMP, cGMP GLP, ISO concepts, international (FDA, EMEA, WHO, ICH, PIC) quality assurance practise
3rd Week
Basic concepts and definitions in GMP
4th Week
Introduction and examine of the GMP guideline of TITCK
5th Week
Requirements according to GMP in pharmaceutical production - production plant
6th Week
Requirements according to GMP in pharmaceutical production - equipment-personnel
7th Week
MID TERM EXAMINATION
8th Week
Requirements according to GMP-Manufacturing-contract manufacturing
9th Week
Requirements according to GMP - Documentation (Records) ? Standart Operation Procedure (SOP)
10th Week
Complaints - Withdrawal
11th Week
Packaging materials - good storage and distribution practices
12th Week
Process validation and types (prospective, retrospective validation)
13th Week
Process validation and types (revalidation and concurrent validation)
14th Week
Good laboratory practices (GLP) and establishment of a laboratory according to GLP
RECOMENDED OR REQUIRED READING
1. Lecturer notes 2. GMP Guideline (TİTCK-2018) 3. Good Manufacturing Practices for Pharmaceuticals Edited by Joseph D. Nally, 2007, Taylor and Francis group,CRC Press, ISBN: 134:978-1-4200-2093-9 (e book)
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Mid-term
1
40
Total(%)
40
Contribution of In-term Studies to Overall Grade(%)
40
Contribution of Final Examination to Overall Grade(%)
60
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
1
2
2
Preparation for Quiz
0
0
0
Individual or group work
14
1
14
Preparation for Final exam
1
8
8
Course hours
14
2
28
Preparation for Midterm exam
1
6
6
Laboratory (including preparation)
0
0
0
Final exam
1
2
2
Homework
1
5
5
Total Workload
65
Total Workload / 30
2,16
ECTS Credits of the Course
2
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)
