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Agenzia Italiana del Farmaco - Italian Medicines Agency Rome, ITALY The Quality Management System Agenzia Italiana del Farmaco - Italian Medicines Agency Rome, ITALY The Quality Management System at AIFA: supporting change INTRODUCTION Origins In the 2 nd semester of 2002 a Quality Management System was created to support the GMP Inspectorate and Manufacturing Authorisations activities. As of mid-2005 the system was extended to all AIFA processes in order to adhere to the Benchmarking of European Medicines Agencies (BEMA) project, whose mission is “To contribute to the development of a world class regulatory system for medicinal products based on a Network of agencies operating to best practice standards. ” AIFA has formulated its own mission in accordance with its founding legislation: Mission The Italian Medicines Agency (AIFA) works to guarantee the right to health stated in article 32 of the Italian Constitution by • Guaranteeing the national unity of the pharmaceutical system in cooperation with the Regions, • Facilitating access to innovative drugs, orphan drugs and medicines for rare diseases, • Promoting the safe and appropriate use of medicinal products, • Supporting investments in pharmaceutical research and development in Italy, • Strengthening relations with Agencies of other countries, with the European Medicines Agency and other international bodies. A Quality Policy has been adopted accordingly: Quality Policy AIFA’s Quality Policy expresses its mission to safeguard the right to health of citizen through a single pharmaceutical system, access to innovative drugs and to drugs for rare diseases, safe and appropriate use of medicines, investment in R&D in the pharmaceutical field, strengthening of relations with EMEA and other Agencies. The above is achieved through: • Efficacy and timeliness of action in the safeguard of public health; • High quality standards in all phases of evaluation, authorisation, control and inspection; • Training programmes aimed at achieving the highest professional competence; • Commitment to operate at the high qualitative standards derived from European Best Practices; • Development of detailed standard operating procedures and their periodical review to achieve continuous improvement; • Attention to all stakeholders in all activities of the Agency, carried out in an impartial and transparent manner; • Diversified internal and external communication aimed at user needs; • Active collaboration within the European agencies network. AIFA is committed to work in accordance to the Quality Management System and to the requirements on which it is based (ISO 9001: 2000). The system will be periodically reviewed to achieve continuous improvement, also through the availability of the necessary resources, which will be guaranteed by the High Management. MATERIALS AND METHODS Mapping Primary and supporting processes of AIFA have been identified and mapped. They are included in SOPs, but are also at the bases of workflow design and re-engineering processes. Quality Manual Quality Policy 146 SOPs Documentation of the Quality System A Quality Manual describes all processes carried out by AIFA and their interactions. It includes a Quality Policy and Quality objectives and describes the means by which these are implemented through a Quality Management System. Interfaces to external partners and service providers are described. Currently 146 SOPs are in force, of which 10 deal with the operation of the Quality System itself. Quality system documentation: guidelines, organigrammes, records, etc. The Quality system documentation collects all documents that contribute to construct a robust system, such as organigrammes, guidelines and all records of quality-related activities. Training and monitoring Staff have been actively involved in the mapping and drafting of procedures process. A six-month period of implementation assistance has followed, during which the understanding of the Quality System was monitored along with the correct application of Procedures. RESULTS AND WAY AHEAD The Quality Management System has proved to be an efficient management tool in conjunction with BEMA self-assessment methodology. In the context of external assessment visits, it provides the backbone for self-representation and discussion. Mapping of processes and SOPs provides interesting insights into connections and/or duplication of activities, allowing for rationalisation and factbased re-engineering where necessary. The development of IT applications can be based on tested and reviewed workflows. Quality Assurance Unit Silvia Fabiani Angela Lombardo