|
Genzyme Pharmaceuticals in Liestal (Switzerland) has undergone a
third-party GMP audit (APIC Audit) of the API Compliance Institute.
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.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
|
