GMP Inspection for VMP by AnsesANMV Vincent NEUVIALE

GMP Inspection for VMP by Anses-ANMV Vincent NEUVIALE, Anses-ANMV

GMP Inspection for VMP by Anses-ANMV : French authority & OIE collaborating centre for VMP • A strong position at the European and International level: expertise, reference (EU-RL and international mandates), research, monitoring, cooperation, training. . . with - European agencies, Commission, organisations, member states - International organisations , non-EU national organisations • PICs member – PICs defines international standards on GMP inspection • Integration of PICs standards on EU GMP rules GMP Inspection steps: • Programming and Planning : Risk based approach • Preparation for inspection : notice for inspection, documentary study, inspection agenda • Carrying out the inspection : different types of inspection, viewed points • Writing and sending initial report : templates for reports, contents (observations and GMP deficiencies) • Assessment of QP responses and conclusion • Compliance status of Veterinary Pharmaceutical Companies and decision

GMP Inspection for VMP by Anses-ANMV Different types of inspection and viewed points Variation in terms of: • Inspection target : System vs. Product inspection • Knowledge of inspectee : Routine vs. Concise inspection vs. Follow-up inspection • Subject of inspection : Routine vs. Quality systems review vs. special inspection • Sponsor of inspection : National vs. European (CVMP)

GMP Inspection for VMP by Anses-ANMV GMP deficiencies • Classification : Sort of the deficiencies regarding to their significance based on PICs and EMA documents Critical Major Other deficiencies • Main GMP deficiencies observed • Assessment of QP responses : final report and compliance status • Follow up : next inspection (frequency based on risk analysis)