Angelini Fine Chemicals’ Quality Management System has been regularly inspected by Italian Medicines Agency AIFA, with the first FDA inspection being conducted in 1979.
Angelini Fine Chemicals is solely committed to Quality in every department within the plant. Angelini Quality Management System encompasses a highly efficient organizational structure, with full resources and processes in order to ensure that quality and safety of products meet all specifications and satisfy customers' needs and expectations.
The quality of the products and processes is checked by the Quality Control laboratories and Quality Assurance on manufacturing site.
Customers can count on strong quality culture and cGMP standards in API manufacturing with a spotless regulatory track record. Angelini Fine Chemicals complies with main regulations and cGMP guidelines for manufacturing of API and is committed to follow a strict Quality policy, approved routinely by main national and foreign regulatory agencies (AIFA, FDA, PMDA).
The process performance and API quality are monitored and controlled during the whole lifecycle of API manufacturing and evaluated by annual product quality reviews (PQR).