Excipient certification scheme launches
pharmafile | February 13, 2012 | News story | Manufacturing and Production | EXCiPACT, GDP, GMP, manufacturing
A consortium of industry associations has launched a certification scheme for pharmaceutical excipients to make it easier for drugmakers to source materials from reliable, quality suppliers.
The EXCiPACT programme takes the form of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards that can be used by auditors – including certified third-party audit organisations – to make sure that an excipient supplier meets the requirements of pharmaceutical manufacturers.
The overall aim is to tighten up security so that excipients which find their way into finished medicines are genuine and of appropriate quality to safeguard public health.
There have been a number of instances in recent years in which adulterated or substandard excipients have resulted in patient harm, such as the 2008 case in Nigeria in which adulterated teething syrup led to the deaths of more than 80 infants.
These incidents are thankfully rare, but other events such as the heparin adulteration scandal and melamine contamination of milk bear witness to the need to increase oversight of increasingly complex and globalised supply chains.
“Regulators expect market authorisation holders to secure their supply chain, and the best way in our opinion to achieve this is to substantially increase periodical, physical audits of manufacturing sites,” said EXCiPACT chair Dr. Folker Ruchatz at a meeting to officially launch the programme in Barcelona, Spain.
It is also generally agreed however that the investment in time and money spent on auditing excipient suppliers can be burdensome, particularly as suppliers spend a lot of time hosting multiple and often duplicative audits from manufacturers.
Certification could cut that workload, with manufacturers also benefitting from being able to either bypass an audit for a certified supplier, or to take EXCiPACT certification as a baseline for GMP/GDP compliance and tailor an audit to their specific circumstances or requirements.
EXCiPACT was originally conceived as an idea almost four years ago, and has been brought to life thanks to the concerted efforts of the five associations behind the project – excipients bodies IPEC Europe and IPEC Americas, the European Fine Chemicals Group, the European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group.
There is already evidence that the pharmaceutical industry is getting behind the programme. For example, the Rx-360 trade organisation which focuses on supply chain security issues in pharmaceuticals has already said it will make use of the EXCiPACT standards in its shared audit programme, which was recently set up to help alleviate some of the burden of multiple, duplicative audits across the industry.
Meanwhile, the attendance of regulators at the launch events, including speakers from the US FDA and UK MHRA, indicates that they are willing in principle to support the scheme.
Much now rides on whether the pharmaceutical industry lends its support, and EXCiPACT is currently looking for companies willing to carry out initial pilot audits in order to help test the standards and qualify the auditing organisations, according to Iain Moore, the programme’s co-ordinator.
“This will also provide a testing ground for all other elements of the EXCiPACT project, not least auditor competency,” he told the launch meeting.
Phil Taylor
Related Content
Ardena announces €20m expansion following first GMP approval
Ardena has announced that it has received Good Manufacturing Practice (GMP) approval from the Dutch …
Lonza to acquire biologics site in Vacaville, US from Roche for $1.2bn
Lonza has announced that it has signed an agreement to acquire the Genentech large-scale biologics …
AbbVie invests $223m in Singapore manufacturing site
AbbVie has announced that it has invested $223m in an expansion to its Singapore manufacturing …
