Manufacturing activities are run under cGMP (current Good Manufacturing Procedures) rules confirmed and granted by Italian Health Ministry during its periodic site inspection. PCA quality system is ISO 9001:2008 approved since 2001 while our environmental system is ISO 14001:2004 approved since 2004 and for both certifications renewal we are regularly inspected by DNV (Det Norske Veritas) on yearly base. Since May 2005 PCA site is US-FDA approved for Ursodiol ( Ursodeoxycholic acid name in the USA) manufacturing and this has been re-confirmed in February 2014 inspection.
Both Ursodeoxycholic acid manufactured and Cholic Acid used as starting material for production process, are covered by CEP (Certificate European Pharmacopoeia ) as granted by EDQM (European Directorate for Quality of Medicines) . More to PCA was first Company worldwide to get this certification for Ursodeoxycholic acid (year 1999).
PCA engagement in high quality product and our more than 30 years experience in bile derivatives field is confirmed by our strict collaboration with Authorities in improving way of testing and quality requirements; we actively participated in developing HPLC test for related impurities as introduced by European Pharmacopoea for Ursodeoxycholic acid testing.
All our API are covered by DMF or when available by CEP, used to support our customers registration in all the countries where they are marketing their drugs.