In the absence of any regulatory framework for GMPs, IPEC–Europe and EFCG are developing a third-party certification system.
The project "could go a long way toward improving quality and, by extension, patient safety," says Iain Moore, chair of IPEC–Europe's
GMP committee. IPEC–Europe and EFCG plan to consult the GMP auditing arm of IPEC–Americas known as IPEA (International Pharmaceutical
Such an approach would allow third-parties such as BSI British Standards or SGS, which provide International Organization
for Standardization (ISO 9001) certificates, to certify that excipient suppliers are operating according to GMP and GDP (good
distribution practice) principles. The appropriate regulatory authority would provide accreditation to the auditing bodies,
explained Tim Boelke, head of EFCG's excipient task force.
With thousands of excipients and suppliers serving the pharmaceutical industry, auditing every potential supplier is a daunting
if not impossible task. Much like the situation in the US, Boelke believes the EU regulatory bodies lack the resources to
carry out so many audits on their own. The authorities, however, can play an important role in auditing by providing independent
oversight and monitoring the process, he says.
Third-party audits are included in the EC's pharmaceutical package but for APIs rather than excipients. In the package proposal,
the regulatory authority's role would be to certify third-party auditing bodies who would then assess the GMP-compliance of
IPEC–Europe and EFCG, along with the United Kingdom's Pharmaceutical Quality Group, are developing a framework for certification
of potential third-party auditors, including an excipient classification scheme and criteria for auditor qualification, training,
and competency. The classification scheme, which may define a GMP level associated with the level of risk to patients, for
example, is a top priority for the councils.
"We need to deliver a draft scheme quickly, as our aim is to present this and a detailed project plan to an invited group
of stakeholders early in 2009 for their comment and feedback," says Moore.
At press time, IPEC–Europe's annual general meeting was taking place in France. Many of the issues addressed here were discussed
and will be reported on at
Phil Taylor is a consultant and writer for the International Pharmaceutical Excipients Council of Europe (IPEC–Europe), firstname.lastname@example.org
. IPEC is made up of four independent associations: the Americas, China, Japan, and Europe (
1. Europe Economics, Excipients: Impact Assessment Report (London), Dec. 19, 2007, available at
http://www.europe-economics.com/, accessed Jan. 13, 2009.