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Pharmaceutical companies have to spend more and more effort to qualify and audit
their suppliers. On the one hand this is due to increasing outsourcing
activities. On the other hand regulating bodies react with more detailed
guidance.
Chapter 5 of the GMP Guide will be amended in order to reflect the new
obligations of manufacturing authorisation holders to only use active substances
that have been manufactured in accordance with GMP. Also, a common approach will
be finalised on what is expected from manufacturing authorisation holders with
respect to the assurance of the quality of raw materials used (the text for
public consultation is expected in 2008). As indicated in a respective
Guidance*, audits at API suppliers are expected every 2-3 years and the
respective report may be reviewed by the authorities. According to EU Guide to
GMP 7.3 (contract manufacture and analysis), the contract giver is responsible
for assessing the competence of the contract acceptor to follow GMP.
One of the most important tools in supplier qualification is the on-site audit.
Although the QP is not obliged to perform the audit him- or herself, the
responsibility stays with the QP. A possibility in saving resources is sharing
an audit.
A survey the European QP Association conducted in early 2007 showed that QPs in
Europe are highly interested in a database comprising shared audits information.
For that reason the association announced during its
2nd QP Forum in November
2007 in Berlin, Germany, that it plans on setting up a database for possible
shared audits. Now it started the exclusive service for members of the
Association.
With the database the QP Association intends to identify suppliers of excipients
and APIs to be audited by more than one pharmaceutical company to enable these
companies to share costs. The audit may be conducted by one of the parties or by
a qualified third party. Simultaneously the European QP Association is
evaluating third party auditing models that comply with the requirements
published by
EMEA in their Q&A Document dated October 2005
(reissued 2006).
To guarantee maximum confidentiality and security for the involved parties, the
association maintains two databases: a "public" database for sharing audits only
contains the ID numbers specifically assigned to each interested party and the
manufacturers' names and the names of the starting materials the parties
supplied. An additional "non-public" database comprises all ID numbers assigned
to the companies interested in shared audits. These two databases allow the
organisation to identify matches and to forward the information to the
respective QPs, only disclosing the names to the partners involved.
More information can be obtained by sending a mail to
audit@qp-association.eu.
Author:
Wolfgang Schmitt
On behalf of the European QP Association
*Guidance on the occasions where it is appropriate for Competent Authorities to
conduct inspections at the premises of Manufacturers of Active Substances used
as starting materials.
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