PAÜ .:. Eğitim Öğretim Bilgi Sistemi

COURSE INFORMATION

Course Code	Course Title	L+P Hour	Semester	ECTS
ECZ 216	QUALITY CONTROL OF DRUG	2 + 0	4th Semester	3

COURSE DESCRIPTION

Course Level	Associate's Degree
Course Type	Elective
Course Objective	This lesson to provide information about raw materials, in process control and control methods which ensure that the consumables and equipment used in the whole process up to the end product, the personnel working and the factors in the environment where this process occurs according to GMP standards.
Course Content	Good manufacturing practices, good laboratory practices, organoleptic controls, physical controls, analytical controls, instrumental analyzes, biological controls, microbiological controls.
Prerequisites	No the prerequisite of lesson.
Corequisite	No the corequisite of lesson.
Mode of Delivery	Face to Face

COURSE LEARNING OUTCOMES

1	Learns GMP and GLP.
2	Explains the issues to be considered during production.
3	Have information about contamination and sterilization.
4	Explain the production stages in the pharmaceutical industry.
5	Have information about personnel, equipment and environment analysis.
6	Knows the situations that will give rejection and approval at the beginning of production.

COURSE'S CONTRIBUTION TO PROGRAM

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION

Activities	Quantity	Duration (Hour)	Total Work Load (Hour)
Course Duration (14 weeks/theoric+practical)	14	2	28
Hours for off-the-classroom study (Pre-study, practice)	14	1	14
Mid-terms	1	5	5
Final examination	1	7	7
Presentation / Seminar Preparation	2	4	8
Internet Searching/ Library Study	2	8	16
Total Work Load ECTS Credit of the Course			78 3

COURSE DETAILS

Select Year

Course Details

Course Code	Course Title	L+P Hour	Course Code	Language Of Instruction	Course Semester
ECZ 216	QUALITY CONTROL OF DRUG	2 + 0	1	Turkish	2023-2024 Spring

Course Coordinator	E-Mail	Phone Number	Course Location	Attendance
Lecturer FETHİ GEÇİMLİ	fgecimli@pau.edu.tr		TMYO A0110	%70

Goals		This lesson to provide information about raw materials, in process control and control methods which ensure that the consumables and equipment used in the whole process up to the end product, the personnel working and the factors in the environment where this process occurs according to GMP standards.
Content		Good manufacturing practices, good laboratory practices, organoleptic controls, physical controls, analytical controls, instrumental analyzes, biological controls, microbiological controls.

Topics

Weeks	Topics
1	Quality Management in Pharmaceutical Industry
2	Good manufacturing practices (GMP)
3	Good Laboratory Practices (GLP)
4	Facility features in Pharmaceutical Industry
5	Initial and raw material analysis
6	Packaging analysis
7	Analysis related to water used in the facility
8	Midterm exam
9	Biological controls and other quality tests
10	Entrumental analysis
11	Calibration and Qualification
12	Validation
13	Preparation of Documentation and Standard Operating Procedures
14	Final Exam

Materials

Materials are not specified.

Resources

Course Assessment

Assesment Methods	Percentage (%)	Assesment Methods Title
Final Exam	60	Final Exam
Midterm Exam	40	Midterm Exam

L+P: Lecture and Practice
PQ: Program Learning Outcomes
LO: Course Learning Outcomes

Prospective Student