GOOD MANUFACTURING AND QUALITY

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).

Learning outcomes

At the end of this learning unit, the student is able to :
1	Students should have the knowledge to organise their work in a quality assurance system and write procedures in relation with it.

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.

Teaching methods

theoretical courses (if sanitary measures allow it), exercices and practical applications, visit of laboratories/industries

Evaluation methods

Students will be evaluated on their ability to
Understand 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