APIC Audit Programme

GMP compliance audits for API manufacturers

The APIC Audit Programme is a third party audit programme to audit manufacturers of Active Pharmaceutical Ingredients (APIs).

This programme was founded by Concept Heidelberg and the APIC, a European Chemical Industry Council (CEFIC) sector group. It was established to create independent and harmonised audit reports. By forwarding these reports to pharmaceutical companies for their supplier qualification API manufacturers can reduce cost and audit frequency. The audits are conducted on the basis of the ICH Q7A (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and with regards to the APIC Auditing Guide. Participation is voluntary and not limited to APIC members.

To implement the programme the APIC and Concept Heidelberg signed an agreement and founded the "API Compliance Institute" in December 2002.

To find out more about the APIC Audit Programme please see at
www.api-compliance.org.