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Italian Medicines Agency Agenzia Italiana del Farmaco

Quality assurance

Quality assurance

AIFA's Quality Management System is based on the principles of quality management described in the UNI EN ISO 9001:2015 standard and the specific rules relating to the activities carried out by the offices involved in the Agency's processes.

In performing the internal audit activity, the Agency follows the indications of the UNI EN ISO 19011:2012 standard, which provides guidelines on auditing, program management and on performing audits of Quality Management systems.

Moreover, as part of its Quality Management System, the Agency shall:

  • ensure the equivalence of inspection and production authorisation activities, subject to international mutual recognition agreements;
  • organise activities relating to internal inspections on Quality Management Systems by national and international organisations;
  • participate in international activities relating to the initiatives of the network of European Regulatory Agencies in the field of Quality Management.

As reference documentation for Quality, the Agency makes use of 200 Standard Operating Procedures (SOP), 7 Management Standard Operating Procedures and Quality Documents.

The AIFA Quality Manual is the main reference document of the Agency’s Quality System, describing the policy, organisation, responsibilities and processes implemented by AIFA within the scope of its competences and responsibilities.

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