[Quality Assurance applied for Drugs & other Pharmaceutical Products
[ First Semester 2018\2019]
Instructor Information
Instructor Email Office Location & Hours
Dr, Abdulatif baroudi] [abdulatifbaroudi@gmail.com [Teachers office from sat. to Wend.8.00-16.00 ]
General Information
Description
- Quality and its requirements, the concept of controlling the quality of Drugs and other pharmaceutical products, the stages of establishing a quality assurance system for pharmaceutical and pharmaceutical products, some variables and the quality reference. In the pharmaceutical establishments, factors influencing the regulatory situation to ensure quality, - the basic rules of good manufacturing practices, the area covered by it, and the cost of obtaining the certificates of management systems, environment and food safety, and the benefits of its application, and De use and the spread of the stages of establishing these systems and the issuing of certificates and adoption of the assessment bodies (laboratories for analysis & measurement)
Expectations and Goals
1- … The definition of the student quality principles and rules of establishment and its relation to the work of the pharmacist and the laboratory with the definition of the quality management systems
2- To inform the student importance of implementing good practices ,quality tools in pharmaceutical plants .
3- … Definition of the activity of 5S, 6 Sigma and its applicability during distribution of the drug storage
4- Providing the student with quality assurance in pharmacy and its products, and clarifying the difference between quality control and quality Assurance
5- 5- Completion of the student's information related to the method of quality assurance, related to the raw material, finished and semi-finished products, the necessary infrastructure,
Language(s) of Instruction: English\arabic Textbook(s) English\arabic
Required Text
ISO- Standards (International standardization Organization ]
Course Schedule
Week Topic Reading Exercises
1 22\9-29\9 Quality and concepts Lec.1 -
2 29\9-6\10 Principles of Quality Assurance and Rules of Organization Lec 2 -
3 6\10-13\10 Good manufacturing practices Lec 3 -
4 13\10-20\10 System of inspection and conformity assessment Lec4- -------
5 27\10-3\11 General requirements for the competence of testing and calibration laboratories Lec 5 =
6 3\11-10\11 Quality assurance of lec pharmaceutical raw materials Lec6 =
7 10\11-17\11 Quality assurance of pharmaceutical products during production Lec 7 =
8 17\11-24\11 Quality assurance of the finished product Lec 8 =
9 24\11-1\12 Quality Management Systems 9001,\2015 Lec 9 =
10 1\12-8\12 Quality environment system 14000 Lec 10 =
11 8\12-15\12 Food Safety Management Systems iso-22000 Lec 11 =
12 15\12-22\12 Other Management Systems: Informatics. IT security, energy, transportation Lec 12 =
13 22\12-29\12 Certification System Lec 13 =
14 29\12\2018-5\1\2019 The accreditation system of the assessment bodies Lec 14 =
15
Testing Schedule
test Date Subject Reading Type language % of final grade
Quizz 1 27\10-1\11\2018 7 lec. /written Arabic/English 10%
Quizz 2 8\12-13\12 7-14 Writing = 10%
Final Exam> 5\1-17\1\2019 Writing\MCQ = 80%
General notes:
- In the course of the lecture, explanatory examples y to simplify the information received in order to understand it, especially the application of international standards related to quality management systems and their application in the field of rehabilitation of medical laboratories and pharmaceutical manufacturing facilities and a system of rehabilitation for obtaining ISO-17025 in the field desired by these laboratories or laboratories National or international award .… the lecture is being modified and updated according to scientific developments ....
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