GMP certificates

The high quality of the active substances and pharmaceutical products is assured by the manufacturers’ compliance with the guidelines on the Good Manufacturing Practice (GMP), as expressly provided for by Directive 2001/83/EC, and as amended by Directive 2004/27/EC.

For medicinal products for human use, the meticulous compliance with these norms is duly verified by the Italian Medicine Agency (AIFA), that is the official body entrusted by the European Authority with the task of inspecting manufacturing sites of active substances, intermediates and medicinal products for human use.

Following such inspections, the AIFA releases a certificate of suitability called GMP certificate. Thanks to the presence of several regulatory experts among its staff, Di Renzo Regulatory Affairs can assist companies in applying for GMP certificates, but also in audits of active pharmaceutical ingredients (APIs) and finished products manufacturing sites, in Italy as well as in other EU and extra-EU countries.

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