QUALITY ASSURANCE: GMP, GCP, GLP AND AUDITING

Lienard Patricia (24 h - 4 ECTS)

After a PhD in Molecular Biology, she worked in private companies in the field of drug development, in different roles covering all aspects of quality assurance and regulatory requirements. As director of operations in accredited labs, she has lead the development and validation of analytical methods used in ISO17025/CLIA/GLP/GCLP/GMP regulatory contexts. As head of production in a CMO specialized in the production of viral vectors, she has supervised the GMP compliance of activities in a sterile/BL3 environment. As head of a clinical unit, she has managed the conduct of phase one clinical trials. Currently director of operations in a company in charge of the supply chain of clinical trials, she supervises the packaging and labelling of IMP, their storage and distribution, as well as the biobanking of human samples.

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