UCL - Good manafacturing and good laboratory practice

[FARM2104]

[30h + 15h] 3 credits

Teacher(s): Joëlle Leclercq(coord.), Véronique Préat

Language: French

Level: Second

Aims
Main themes
Content and teaching methods
Other information (prerequisite, evaluation (assessment methods), course materials recommended readings, ...)

Aims

Students should have the knowledge to organise their work in a quality assurance system and write procedures in relation with it.

Main themes

Teaching will deal with good manufacturing practice 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.

Content and teaching methods

Student will receive a theoretical formation on
- good manufacturing practice and assessment of a quality control. They will visit industries
- good laboratory practice and development of a quality assurance system. They will visit laboratories (research and industry) working in a quality assurance system and will receive practical information in discussions and seminars

Other information (prerequisite, evaluation (assessment methods), course materials recommended readings, ...)

Prrequisite :
pharmaceutical technology, analytical chemistry and instrumental

Evaluation:
Evaluation will be done on their aptitude to understand philosophy of GMP, GLP and quality assurance and to write simple procedure(s).