[drug quality control] Syllabus
[1st semester – 2018 – 2019 ]
Instructor Information
Instructor Email Office Location & Hours

General Information
Description :
Detailed interpretation about Drug Quality and the control techniques and procedures through all manufacturing steps (establish specifications, purchasing of raw and packaging materials and , processing ,storage , release and distribution ),till pharmacies and dispensing ,and laboratory equipment and documents including Quality tools , and international and local legislation in the field of drug Quality ( Quality Control ) .
Expectations and Goals
Enable the student:
1- to know quality principles of medicines .
2- how to implement Pharmaceuticals Quality system and documentation .
3- understand quality of QC laboratory .
4- how to apply batch production& packaging records .
5- cleaning and control sterile production environment .
Language(s) of Instruction: Textbook(s) Language(s)
Arabic English
Course Materials
Required Text
Quality assurance of medicines
Laboratory quality system
GMP ( FDA-WHO )
[Item Name] [Media Type], [Author Name]
Course Schedule
Week Topic Reading Exercises
1 22.9.2018 Drug quality principles Power point Practical section
2 29.9.2018 Drug quality principles Power point Practical section
3 6.10.2018 Drug quality principles Power point Practical section
4 13.10.2018 Batch production & packaging records Power point Practical section
5 20.10.2018 Pharmaceuticals quality system Power point Practical section
6 1STtest 27.10.2018 Pharmaceuticals quality system Power point Practical section
7 3.11.2018 Laboratory quality system Power point Practical section
8 10.11.2018 Laboratory quality system Power point Practical section
9 17.11.2018 Cleaning in pharmaceutical plan Power point Practical section
10 24.11.2018 Cleaning in pharmaceutical plan Power point Practical section
11 1.12.2018 Cleaning in pharmaceutical plan Power point Practical section
122testnd 8.12.2018 Environment control in sterile production department Power point Practical section
13 15.12.2018 Environment control in sterile production department Power point Practical section
14 22.12.2018 Environment control in sterile production department Power point Practical section
15 27.12.2018 Environment control in sterile production department Power point Practical section
Testing Schedule
test Date Subject Reading Type language % of final grade
Quiz 1 Drug quality principles Power point MCQs Arabic
Quiz 2 Pharmaceuticals quality system Laboratory quality system
Cleaning in pharmaceutical plan Power point MCQs Arabic
Exam All Power point MCQs+ written Arabic
General notes: