Inspections and Certification

One of the tasks of AIFA is to co-ordinate the inspections at manufacturing sites of finished medicinal products and medicinal gases in order to ensure compliance with EU Good Manufacturing Practice and related guidelines. All sites on the Italian territory are regularly inspected, in order to guarantee consistency in the manufacturing process of medicinal products and an adequate pharmaceutical quality of the finished dosage form.

The Agency also co-ordinates all the activities necessary to maintain the equivalence of the Italian Inspection System with the other Member States of the EU and with Countries that have a Mutual Recognition Agreement on Inspections with the EU.

Moreover, AIFA representatives actively participates to Working Groups, Expert Circles and related initiatives of European and International organisms competent for inspections (EMEA, PIC/S and WHO).

The Agency also conducts inspections at manufacturing sites producing raw materials that make up the pharmacologically active medicines to ensure quality standards.

Aifa also verifies the implementation of national and European laws regarding the distribution, importation, exportation and smooth operation of early warning and emergency management.

In addition, the Agency monitors the activities of any suspension and or revocation of marketing authorizations for medicinal products. In all cases where the lack of perceived quality can lead to serious health risk, even regarding the medicinal products marketed abroad, AIFA is responsible for activating an International alert through the network of information exchange in the production and quality (Rapid Alert System, RAS).

With respect to inspections, the Agency carries out the activities related to imports for some types of medicines, to the monitoring and management of drug shortages and to the administrative management of the inspection certificates issued by other EU countries, according to European guidelines.

Furthermore is AIFA responsibility to check and then allow the importation of plasma needed for the production and export of pharmaceutical derivatives.

Contacts

	Manufatcuring Authorisation Head of Office: Renato Massimi Phone: +39 06 59784477 Fax: +39 06 59784424 E-mail: r.massimi@aifa.gov.it
	GMP Inspectorate Head of Office: Giuseppe Pimpinella Phone: +39 06 59784476 Fax: +39 06 59784149 E-mail: g.pimpinella@aifa.gov.it

Authorization for the Manufacturing Sites, revoke, Import / Export, Alert System for  the reporting of defects in quality of medicines:
Fax: +39 06 59784313

Shortages of medicines and imports of medicinal products not allowed in the Italian territory:
Fax: +39 06 59784312