Agence Nationale de Sécurité des Médicaments et des produits de santé (ANSM) - French National Agency for Medicines and Health Products Safety
Thomas Lucotte, as agronomist, had been working in QA and QC in food industry for seven years. He had also been a trainer and consultant in hygiene in clean rooms, quality systems, environmental and safety policies for five years. After these experiences, he became QA Manager in a French GLP test facility which performs viral safety and cell banks characterization studies during five years.
Thomas Lucotte has been GLP inspector at ANSM since February 2012. He has been attending the GLP OECD and European Union Working Groups since 2012 as France’s medical products representative and took part of different harmonisation issues sub-groups.
Food and drugs quality systems and standards, risk assessment, auditor, management.
OECD Document on Test Item Management: What is New?
Since its issuance, the clarifications given in Document No. 19 on the GLP requirements have been implemented in the GLP test facilities. This presentation aims to underline the clarifications that could be considered as quite new compared by the GLP principles and to explain how to understand them from a monitoring authority point of view and the linked expectations.
Some questions received from stakeholders and possible answers would be also presented.