Merck, Hedinger first suppliers certified under excipient scheme
pharmafile | August 1, 2013 | News story | Manufacturing and Production |Â Â Merck, Merck KGaAÂ
Merck KGaA’s EMD Millipore unit and fellow German firm Hedinger have become the first two excipient suppliers to be certified under the EXCiPACT scheme set up last year.
EXCiPACT was set up last year by the IPEC Federation – an umbrella organisation representing excipients suppliers and users from around the world – and can be used to show that a supplier meets Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
Under the EXCiPACT scheme, third-party auditors – in the case of EMD Millipore it was Germany’s mdc GmbH – assess a supplier and certify that the organisation was working to agreed standards on processes such as quality management systems, manufacturing, testing and release, and storage and distribution.
Once certification is in place pharma customers can have confidence sourcing excipients from them without necessarily having to expensive, time consuming and often redundant site audits. At least one other supplier has been certified – also from Germany – but had not been identified at the time of writing.
In a statement, the EXCiPACT Association said the requirement for site audits by theFDA and the European Medicines Agency (EMA) “continues to be pressed for pharmaceutical excipients and, as a result, their suppliers must be prepared to receive increasing numbers of audits from their customers”.
Iain Moore, chair of the EXCiPACT Association, told Pharmafile that a further three organisations have participated in a series of pilot audits, adding: “we anticipate more certificates in the near future”.
The decision to set up a certification scheme came in the wake of a number of cases around the world in which excipients were linked to patient harm, such as the 2008 case in Nigeria in which adulterated teething syrup led to the deaths of more than 80 infants.
The 2008 case in Nigeria – and others in Panama, Argentina, Bangladesh, India and Haiti over the last 20 years – involved liquid medicines made using glycerin adulterated with toxic diethylene glycol (DEG).
“Thousands of excipients are present in medicines and the quality of these materials is critical to ensure patient safety,” according to Burghard Freiberg, senior vice president, pharmaceutical chemicals at EMD Millipore.
“This EXCiPACT audit will assure our customers they are incorporating only the highest quality excipients into their formulations and we have minimised risk in their supply chain,” he said, adding: “We encourage all manufacturers of excipients to undergo the same audit.”
Phil Taylor
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