Medicines, vaccines and advanced therapies

Checks on compliance with GMP

A key aspect of the production of medicines is the verification of compliance with Good Manufacturing Practice (GMP). By law, this task is entrusted to the Italian Medicines Agency (AIFA) which makes use of experts from the Italian National Institute of Health (ISS), mostly from the National Center for the Control of Medicines (CNCF) and the Biological Service (BIOL). Following an adequate training process, these experts operate as inspectors and collaborate in teams with AIFA to inspect the numerous pharmaceutical workshops residing in Italy and abroad, in a non-European context managed by the European Medicines Agency (European Medicines Agency, EMA).

The activity is focused both on workshops that produce pharmacologically active raw materials and on those that produce finished products. The inspection activity plan to verify compliance with the standards of good manufacturing practice at pharmaceutical workshops is the subject of an agreement with AIFA which manages all requests for the various necessary activities. The CNCF, on an accrual basis, coordinates the inspectors of the ISS so that AIFA subsequently organizes, according to its own procedures, the inspection teams, allocating them to the various companies to be inspected. Given the need to inspect an increasing number of pharmaceutical workshops operating highly advanced production processes, it is also the CNCF’s job to stimulate the recruitment and training of additional experts/inspectors at all ISS facilities to further increase the inspections and thus meet the AIFA requests.