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10 April 2008

European QP Association Initiates Shared Audit Database

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.

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.

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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