Last week the firm – a unit of German drugmaker Merck KGaA – became the first major excipient supplier certified under IPEC Federation’s Excipact excipient scheme after an assessment by mdc medical device certification GmbH/blue inspection body.
The audit covered “sourcing, manufacturing, testing, packaging, storage and release of products of the Emprove exp and Emprove bio lines…supplied from the Merck site in Darmstadt” according to EMD spokesman Frithjof Holtz.
He told in-Pharmatechnologist.com that auditors had assessed incoming goods, warehousing and sampling areas, as well as those used for solvents and the QC labs where the firm’s excipients like mannitol, sorbitol and hexahydrate are tested.
They also looked at suppliers according to Holtz, who said while they stopped short of site visits “the procedures for the supplier evaluation, the roles and responsibilities, the details of the process and the documentation have been carefully evaluated by the auditors.”
Move in the right direction
No matter how robust or well intentioned, industry-led voluntary assessment schemes are almost always the subject of criticism from those who would prefer formal regulatory oversight. With this in mind we asked Holtz, who is vice chair of IPEC Europe, how valuable Excipact certification will be for EMD Millipore.
He said that: “Excipact certification is a move in the right direction combining best practices and in industry broadly accepted appropriate cGMP and cGDP standards for pharmaceutical excipients combined with a state of the art third party auditing program.”
Holtz predicted that certification will be well received by suppliers and users of pharmaceutical excipients as the current challenges as the appropriate GMP, and GDP, and the physical audits are covered by the scheme.
“Whether in the long term regulators will set binding GMP and GDP standards for excipients is difficult to say,” he added.
He gave the example of the 2004 draft EU Certain Excipients Directive whose requirement that API-standard GMP be applied to high risk excipients has not been implemented because it places a ‘disproportional burden’ on the industry.
“The EU Falsified Medicines Directive, Directive 2001/62/EU, and the resulting risk assessment to define the appropriate GMP for excipients is the logical consequence. However, formal GMP for excipients and the enforcement by the regulators would lead to a level playing field, reaching also those who do not participate in schemes as Excipact.”