Due to the COVID-19 crisis, the information below is subject to change,
in particular that concerning the teaching mode (presential, distance or in a comodal or hybrid format).
3 credits
30.0 h + 15.0 h
Q2
Teacher(s)
Leclercq Joëlle (coordinator); Pronce Thierry; Préat Véronique;
Language
French
Main themes
The course will cover the basic principles of Pharmaceutical Quality Assurance as well as the standards and legislation applicable to laboratory work in the pharmaceutical industry (R&D, clinical development and quality control).
Aims
At the end of this learning unit, the student is able to : | |
| 1 | 1. Understand the different standards applicable to laboratory activities in the pharmaceutical industry 2. Understand and apply the essential elements (staff training, documentation, life cycle of an analytical method, equipment management, reference standards and critical reagents and sampling) 3. Organize your work in a quality assurance system 4. Write the necessary procedures for its maintenance. 5. Know how to establish the specifications of a drug 6. Know how to establish and interpret a control chart |
Content
Students will receive theoretical training
- on good laboratory practices and the implementation of a pharmaceutical quality assurance system. They will visit pharmaceutical industries.
- on good laboratory practices and the implementation of a quality assurance system.
They will visit laboratories (research and pharmaceutical industry) working in quality assurance and will receive practical training in the form of discussions and seminars.
- on good laboratory practices and the implementation of a pharmaceutical quality assurance system. They will visit pharmaceutical industries.
- on good laboratory practices and the implementation of a quality assurance system.
They will visit laboratories (research and pharmaceutical industry) working in quality assurance and will receive practical training in the form of discussions and seminars.
Teaching methods
Due to the COVID-19 crisis, the information in this section is particularly likely to change.
theoretical courses (if sanitary measures allow it), exercices and practical applications, visit of laboratories/industries
Evaluation methods
Due to the COVID-19 crisis, the information in this section is particularly likely to change.
Students will be evaluated on their ability toUnderstand the philosophy of Good Laboratory Practice and Pharmaceutical Quality Assurance,
write one or more simple procedures (personal work)
know how to establish the specification of a drug
be able to evaluate the performance criteria of an analytical method
Establish and interpret a control chart
The exam will be written (face-to-face or distance).
Other information
Prequisite : pharmaceutical technology, analytical chemistry and instrumental
Evaluation will be done on their aptitude to understand philosophy of GMP, GLP and quality assurance and to write simple procedure(s).
Faculty or entity
FARM
