The Qualified Person's (QP) function and responsibility within European pharmaceutical legislation is unique. The approach
requires the QP to certify each batch of finished product within the EC/EEA before it is released for sale or supply, and
to have an oversight of the respective quality systems.
The Directives 2004/27/EC (human drugs) and 2004/28/EC (veterinary drugs) mandate that only APIs manufactured according to
GMP standards for starting materials (laid down in Part II of the EU Guide to GMP) can be used for the manufacture of medicinal
products. The responsible QP must satisfy himself/herself that these provisions are met and that a procedure of supplier qualification
is in place.
The procurement of all starting materials requires the API supplier to be assessed using a supplier qualification procedure
to ensure the supplier is operating adequately and complying with GMP. This does not necessarily have to be conducted by the
QP of the manufacturer's authorisation holder personally (although some member states do require this), but the QP will require
"assurance" that the audit has been conducted correctly.
On-site audits of all active substance manufacturers and suppliers are expected by all regulatory authorities and inspectorates.
Inspection reports by regulatory authorities — if available — can be taken into account when assessing a supplier, but cannot
replace the supplier audit performed by the pharmaceutical manufacturer or manufacturing authorisation holder itself. Shared
audits and third party audits where the auditor has no conflict of interest, however, are generally accepted by regulatory
authorities. Such audits offer enormous potential for reducing workload.
Introducing the QPSHARE database
To help QPs make the most of the potential of shared audits, the QP Association has developed the QPSHARE database for its
The project first began in April 2008 when the QP Association tried to facilitate the possibility of shared audits. All members
of the QP Association were asked to submit data about suppliers they were interested in auditing, and for which they may be
interested in performing shared audits of. These data were used to identify the suppliers that more than one QP wanted to
audit, and the relevant QPs were then informed. There was no further involvement from the QP Association and all proceeding
activities were up to the QPs involved.
During this process, a lot of data were generated and it was necessary to implement a more suitable database that could standardise
and manage the given information efficiently. Hence, QPSHARE was created.
Since the creation of the database, the process has changed slightly. The user himself can now identify suppliers where more
than one QP is interested in performing an audit. At this stage, the names of the QPs identified are not displayed, granting
full confidentially, but it is possible for the user to contact the other QPs via the system. At this point, the QP Association's involvement ends and the QP(s) who were contacted can decide whether to disclose
their identity and contact the enquiring colleague.
If contact does occur, it will give the QPs involved the opportunity to discuss directly how to build up a relationship in
qualifying this certain supplier. They may decide to share the audit, with one auditor of each company joining the audit team.
Given the fact that it is expected and recommended to perform certain audits with at least two auditors, this will decrease
the cost of the audit for each company by 50%. They can also decide to entrust the audit to a third party, and share both
costs and information. Another option could be to share or exchange existing audit reports.
The choice is up to the QPs involved and requires only the agreement of the audited supplier.
Bernd Renger Vice President Quality Control at Vetter Pharma-Fertigung GmbH & Co. KG (Germany)