Course Overview

This course will present the theory and methods of analytical method
used for quality control of finished product in pharmaceutical
industry with a focus on falsified product detection.

Learning Achievement

Competence

Course prerequisites

- Hold a bachelor or master of pharmacy or analytical chemistry with
knowledge on pharmaceuticals 
- English level: B2 
- Computer with excel application and internet connection

Grading Philosophy

Module 1 &2: 
- Quizzes  - 1h - 25 % weight of overall mark  Module 3&4: 

- Written exam: Exercises on sample preparation, analysis, counterfeit
detection  - 1h  - 50% weight of overall mark  Module lab work: 

- Report on the lab work  - 1h  - 25% weight of overall mark 
RULES AND PROTOCOL FOR FAILURES 
- Overall mark ⩾ 10/20  - Module mark ⩾ 7,5/20

Course schedule

Module 1: Introduction to quality control: 
- Regulation texts that define the quality of medicines  - Quality
control and quality assurance  - Raw material and API  - Finished
products  - Packaging (extractible and leachable)  - Quality risk
management, Quality by Design and quality Control Module 2: Sampling
and sample preparation: 

- Sampling  - Sample preparation: method of extraction, solubility
and stability  Module 3: Analytical techniques for quality control of
finished product: 
- Gas Chromatography  - Liquid Chromatography  Module 4: Falsified
product control: 

- Definition  - Methods and techniques for counterfeit products
detection  - Examples

Course type

- Lectures and tutorial in remote (zoom and moodle)  - Face to face lectures  - Face to face lab work (in Bordeaux, faculty of pharmacy) - 75 hours= 41 contact hours (18 lectures, 9 tutorials, 14 lab work, 6 exam); 34 hours self-study (10private reading,8 writing assessment, 6 exam preparation, 10 group work preparation) 

Online Course Requirement

Instructor

Other information

- Maximum number of students: 30
- Selection procedure is stated: Online application + Interview
- Selection criteria: bases in analytical chemistry and statistics

Duration: 41h: 18 h lectures and, 9h Tutorials, 2 days lab work

Language of instruction: English
Mode of delivery: Face-to-face teaching and distance-based

Site for Inquiry