GOOD MANUFACTURING AND QUALITY

Teacher(s)

des Rieux Anne; Leclercq Joëlle (coordinator); Pronce Thierry;

Language

French
> English-friendly

Main themes

Teaching will deal with good manufacturing procedures in pharmacies and in industry and good laboratory procedures in laboratories as well as legislation and norms related to quality assurance, advantages to work in a quality system and organisation that it implies.

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

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