drug quality control

drug quality control

[1^st semester – 2018 – 2019 ]

Instructor Information

Instructor	Email	Office Location & Hours
Dr. Rajwa Jbeily	rajwajbeily@gmail.com	Location, Hours, Days

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 )

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 1^STtest	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
122test^nd	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