Excipient certification scheme launches in US
pharmafile | May 17, 2013 | News story | Manufacturing and Production |Â Â EXCiPACT, GMPÂ
A certification scheme for pharmaceutical excipients to make it easier for drugmakers to source materials from reliable suppliers made its US debut at the ExcipientFest exhibition in Baltimore, about a year after being launched in Europe.
EXCiPACT is a voluntary scheme that allows excipient suppliers to be audited by an independent third party organisation against an agreed set of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
Since its launch last January in Europe, EXCiPACT has been put through its paces with a series of test audits on volunteer suppliers carried out by two registered certifying bodies (SGS and Blue Inspection) and witnessed by independent experts, along with training days to instruct auditors on the use of the scheme.
The overall aim is to certify that an excipient manufacturer is working to the agreed GMP and GDP standards, so pharma customers that approach the supplier can be confident that those standards are being met without the need to conduct expensive, time-consuming and often redundant audits themselves.
At the heart of the objective is patient safety. There have been a number of instances in recent years in which adulterated or substandard excipients have resulted in patient harm, such as a notorious 2008 case in Nigeria in which contaminated teething syrup led to the deaths of more than 80 infants.
Drugmakers who source excipients from EXCiPACT-certified suppliers should have greater confidence that they are using quality ingredients.
Around 100 stakeholders representing designers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, plus regulatory bodies and academia, attended the US launch event in Maryland.
A website set up for EXCiPACT gives background information on the scheme access to the EXCiPACT GMP and GDP standards, information and guidance on the certification process plus auditor training requirements, training sessions and qualifications.
Lists of approved third party audit organisations, approved auditors and certified organisations will be added as they become available.
Phil Taylor
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