Excipient certification project moves forward
pharmafile | December 4, 2012 | News story | Manufacturing and Production |Â Â DEG, EXCiPACT, GDP, GMPÂ
The EXCiPACT certification scheme for pharmaceutical excipients has taken a step closer to fruition with agreements now in place with two third-party auditing bodies.
The organisers of the new scheme – which is designed to make it easier for drugmakers to source materials from reliable, quality suppliers – signed framework agreements with Blue Inspection Body GmbH and SGS late last month.
EXCiPACT was launched in January and takes the form of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards that can be used by auditors to make sure that an excipient supplier meets the requirements of pharmaceutical manufacturers.
Regulators in the EU and US require the holder of the marketing authorization for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients.
Using the EXCiPACT scheme, third-party auditors can assess a supplier and certify that the organisation was working to the agreed standards. Thereafter, pharma customers could approach that supplier confident that those standards were in place, without the need to conduct expensive, time consuming and often redundant audits themselves.
The EXCiPACT Association – set up by excipients trade group the IPEC Federation – has been training SGS and Blue Inspection auditors who will now carry out pilot audits using the standards, and said it is also talking to other certifying bodies interested in joining the scheme.
The pilots – on volunteer excipient suppliers – will be independently monitored to verify that the standards and the auditor training have been defined and implemented correctly. If so, they would then be able to offer EXCiPACT certification services to clients.
There have been several 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.
Earlier this month there were reports of deaths linked to cough syrup in Pakistan, although debate is still raging about whether these were a result of overdosing or some form of quality defect.
In Nigeria and other past incidents, fatalities were caused by liquid medicines made using glycerin adulterated with toxic diethylene glycol (DEG).
Phil Taylor
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