ANMV – Quality management
For several years now, the French Agency for Veterinary Medicinal Products (ANMV) has been committed the establishment of a quality management system with national, European and international recognitions.
In September 2013 this commitment lead to ISO 9001 certification for the ANMV, which has been renewed according to the new ISO 9001-2015 standard version (ISO 9001 certificate, pdf).
The certification covers the following scope of activities :areas
“Provision of a scientific expertise as regards veterinary medicinal products in compliance with the requirements of the NF X 50 110 standard, authorisation of veterinary medicinal products and veterinary pharmaceutical facilities and control of marketed veterinary medicinal products. At international level, provision of expertise and capacity building as regards veterinary medicinal products' governance.”
The ANMV also obtained the following recognitions:
- As a member of the European network of Official Medicines Control Laboratories (OMCLs), the laboratory of the market surveillance unit has participated since 2007 in the Mutual Joint Audit, a programme organised by the European Directorate for the Quality of Medicines and HealthCare (EDQM). This recognition was renewed in December 2015.
- In 2008, an assessment was conducted with regard to the work methods and quality management system for inspections. On 1 January 2009, the French Agency for Veterinary Medicinal Products obtained the following recognitions: the Joint Audit Program (Europe); the Pharmaceutical Inspection Cooperation Scheme (international).
- In 2012, an assessment of the system for inspecting testing facilities conducted by the OECD enabled the ANMV to obtain the renewal of its compliance recognition as the competent authority for the inspection of good laboratory practices in the field of veterinary medicines.
The ANMV also takes part in the European benchmarking exercise (BEMA) in which all the competent European authorities for human and veterinary medicinal products participate. This exercise is an assessment of the agencies by their peers (auditors from other European agencies), based on a questionnaire which applies the requirements of the ISO 9001 standard. This exercise is a veritable tool for improving the quality management approach supported by ANMV management.
A quality policy declaration by the Agency’s director (pdf, in French) is testimony to the ANMV’s commitment to quality management, establishing a process-based approach and, more recently, a risk-based approach.
The ANMV has a complaint management procedure which is available upon request from the quality manager.