QUALITY ASSURANCE: GMP, GCP, GLP AND AUDITING
Lienard Patricia (24 h - 4 ECTS)
Theory: 24 h
Title | Quality Assurance : GMP, GCP, GLP and Auditing (4 ECTS) |
Program
|
As an introduction, the principles of quality assurance in the field of healthcare and drug development are depicted. Then, the international standard ISO17025 is reviewed in details to give a complete overview of a quality system with organizational and technical requirements. The next chapters cover the different GxP standards: -GLP (good laboratory practices) for the pre-clinical studies -GCP (good clinical practices) and GCLP (good clinical laboratory practices) for the clinical studies -GMP (good manufacturing practices) and GDP (good distribution practices) for drug production and distribution Finally, a chapter is dedicated to the concept of validation in the broad sense of the term, to cover all the topics concerned by qualification or validation needs (equipment, process, methods, IT systems….) 1 : Introduction to quality assurance 2 : ISO17025 3 : GLP 4 : GCP/GCLP/ISO15189/CLIA 5 : GMP/GDP 6 : validations |
Sources |
ISO17025 and ISO15189 Monographs GLP OCDE GCP ICH E6 GCLP EMA Eudralex Volume 4 GDP EU |
Objectives and expected results | All the aspects of Quality Assurance in the development and life cycle of drugs are reviewed. |
Prerequisites | None. |
Teaching methods |
Powerpoint Presentations Exercises Analyse of documents Practice of GXP activities Presentation by students of document analysis |
Exam modality | Written exam. |
TITLE
Quality Assurance : GMP, GCP, GLP and Auditing (4 ECTS)
PROGRAM
As an introduction, the principles of quality assurance in the field of healthcare and drug development are depicted. Then, the international standard ISO17025 is reviewed in details to give a complete overview of a quality system with organizational and technical requirements. The next chapters cover the different GxP standards:
-GLP (good laboratory practices) for the pre-clinical studies
-GCP (good clinical practices) and GCLP (good clinical laboratory practices) for the clinical studies
-GMP (good manufacturing practices) and GDP (good distribution practices) for drug production and distribution
Finally, a chapter is dedicated to the concept of validation in the broad sense of the term, to cover all the topics concerned by qualification or validation needs (equipment, process, methods, IT systems….)
1 : Introduction to quality assurance
2 : ISO17025
3 : GLP
4 : GCP/GCLP/ISO15189/CLIA
5 : GMP/GDP
6 : validations
SOURCES
ISO17025 and ISO15189
Monographs GLP OCDE
GCP ICH E6
GCLP EMA
Eudralex Volume 4
GDP EU
OBJECTIVES AND EXPECTED RESULTS
All the aspects of Quality Assurance in the development and life cycle of drugs are reviewed.
PREREQUISITES
None.
TEACHING METHODS
Powerpoint Presentations
Exercises
Analyse of documents
Practice of GXP activities
Presentation by students of document analysis
EXAM MODALITY
Written exam.
Last modified: April 29, 2021