AIFA and FDA regulatory activities

The Agenzia Italiana del Farmaco (AIFA) and US Food and Drug Administration (FDA) are international Regulatory Authorities responsible for protecting public health by assuring the safety, effectiveness, and quality of human and veterinary drugs.

In order to guarantee quality and safety of medicinal products, AIFA and FDA inspect and monitor production sites to check compliance to Good Manufacturing Practice, cGMP for the whole production process and raw materials.

cGMP are guidelines that have to be applied, as part of a quality control system, to guarantee batch consistency and compliance to product specification as stated in registration dossier.

In addition AIFA and FDA ensure that inspection systems in Italy and in US are equivalent to that in other European Countries and third countries for which a reciprocal recognition about inspections is in place.

Procelltech operates in full compliance to cGMP guidelines. Procelltech have initiated iter for facility authorization and inspection from AIFA is awaited by end of 2010.