Duration
10h Th, 10h Pr
Number of credits
| Master in biomedicine (120 ECTS) | 1 crédit |
Lecturer
Eric Claessens, Lucas Fotsing, Philippe Hubert, Roland Marini Djang'Eing'A
Substitute(s)
Language(s) of instruction
English language
Organisation and examination
Teaching in the second semester
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
GMP: Introduction and general provisions, Quality management and GMP documentation system, GMP and management of staff, premises, equipment and management of GMP manufacturing; General provisions and international health institutions such as the World Health Organization (WHO).
GMP and GMP sterile manufacturing: introduction to Good Manufacturing Practices (GMP) documentation and to basic GMP requirements for the production of sterile drug manufacturing, including the control of endotoxins in these products. This introduction covers the origin of GMP as well as the purpose and proper use of a pharmaceutical documentation system, and the basic requirements for sterile manufacturing (potential impact of staff (hygiene, behaviour, clothing), impact of infrastructure and air-conditioning systems in the prevention of microbial or particulate contamination as well as the management and control of endotoxins, introduction to viable and non-viable environmental monitoring techniques).
GLP (Good Laboratory Practices) and Quality Control, Subcontracting, Audits, Complaints and batch recalls, GMP Research and Development and other regulations (ISO, FDA, Pharmacopoeias, etc.).
Audits - Supplier audit: theoretical and practical aspects of audits in general and supplier audits in particular.
The guiding principle of GMP is that quality is integrated into the product and not simply tested on the finished product. Consequently, quality assurance not only means that the product meets the final specifications, but that it was obtained through a process controlled by a well-proven and continuously improving quality system. As a result, audits are a keystone of GMP.
In this module, students will learn about: the legal bases, the definitions, and the different types of audit (internal, external, inspection, audit by a third party, etc.).
They will then look at the practical elements for conducting an audit and preparing the report. The different practical situations will be discussed based on the key documents of an audit, such as a confidentiality agreement, a schedule, a practical guide with the key points, a certificate and a report. Students will be given an example of all these elements.
Learning outcomes of the learning unit
Students will learn the basic notions of the workings and use of a quality system that meets the standards of Good Manufacturing Practices.
Students will learn the basic notions governing the manufacturing of sterile dosage forms including the main sources of microbial, particulate or endotoxin contamination of manufactured products and its prevention.
Students will acquire the theoretical and practical notions to conduct an internal and external audit. The aim is that by the end of this course, students should have sufficient organisational knowledge to join a team of auditors.
Prerequisite knowledge and skills
Planned learning activities and teaching methods
Intervention of external experts (pharmaceutical industry)
Mode of delivery (face to face, distance learning, hybrid learning)
Face-to-face
Recommended or required readings
Condensed notes and PPT presentations
Any session :
- In-person
written exam AND oral exam
- Remote
written exam ( open-ended questions ) AND oral exam
- If evaluation in "hybrid"
preferred remote
Additional information:
Written and oral exam depending on the parts
Work placement(s)
Possibility of doing a placement
Students may be able to participate in a real audit.
Organisational remarks and main changes to the course
If some of the external contributors are unavailable (industrial world), it may not be possible to cover the entire subject during the first quadrimester. In this case, the classes in question will be postponed in consultation with the students, in accordance with the agreement taken with the Board of Studies.
Contacts
Philippe Hubert
Service de Chimie analytique, Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1
Tel. : 04/366.43.16 (15)
e-mail: ph.hubert@uliege.be
Roland Marini
Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1
Tel. : +32 4 3664318
e-mail: rmarini@uliege.be
Secrétariat :
Murielle Bihain
Tel. : 04/366.43.16
Fax : 04/366.43.17
e-mail: mbihain@uliege.be