APIC, the body representing European manufacturers of active pharmaceutical ingredients, has taken steps to help ensure the quality, safety and efficacy of medications taken by European consumers. 

“Both outsourcing of manufacturing as well as global sourcing of raw materials have become key elements of the strategy of many companies in the pharmaceutical environment,” says Chris Oldenhof, President of APIC. “This usually makes business sense, but the industry must strictly monitor and manage the capabilities of external suppliers. We want to secure the quality, safety and efficacy of medicines by effective monitoring of the entire manufacturing chain during the whole product life-cycle, so that patients worldwide can be fully confident of their medication, wherever its various components have been manufactured”.

This is why APIC has launched its official “Quality Agreement” and “Supplier Qualification and Management” Guidelines, which will facilitate and improve the cooperation and communication between suppliers and customers, and thereby contribute to a secure supply chain.

APIC encourages both API/intermediate manufacturers and their customers to use and further promote these guidelines. 

The guidelines and pertinent templates and checklists can be found on the APIC website, at http://apic.cefic.org/.

For further information, contact

Pieter van der Hoeven

APIC Managing Director

Tel. +32 2 676 7202