GMP News No. 557
20 May 2005
Third-Party GMP Audit at Genzyme Pharmaceuticals
The API Compliance Institute was founded on 19 December 2002 by APIC, a sector group of CEFIC, and CONCEPT HEIDELBERG. It is the aim of this initiative to conduct independent GMP audits (so-called third-party audits) at manufacturers of active pharmaceutical ingredients. These GMP audits are subject to strict conditions and can be commissioned by the API manufacturer themselves or by a pharmaceutical company (for the qualification of an API supplier).
The aim is to check the GMP compliance status on the basis of the ICH Q7A Guidance "GMP for Active Pharmaceutical Ingredients".
The assessment is done by 2 auditors, who write a comprehensive audit report afterwards. This audit report can be passed on by the API manufacturer, i.e. the API manufacturer can place this comprehensive GMP assessment at the disposal of the customers as a supplier qualification. In this way, costs can be reduced both on the part of the API manufacturer and on the part of the pharmaceutical company.
Today, third-party audits are a measure accepted by international supervisory authorities within the framework of supplier qualification. In the US, such third-party auditing models exist in the fields of excipients and software.
You can read a report on the experiences gathered in a GMP audit at Genzyme Pharmaceuticals if you click here.
More information on the API Compliance Institute can be found if you click here. This website includes among others APIC's Best Practice Guides, e.g. on Cleaning Validation or Technical Change Control.