EMD Millipore is the first firm named as having passed the scheme to date, although in-Pharmatechnologist.com understands that auditing group mdc medical device certification GmbH/blue inspection body has issued at least one other certificate.
Details of the audit have not been disclosed but the certification means EMD Millipore’s production and handling of excipients meets appropriate good manufacturing and distribution practices (GMP/GDP) standards.
This is something drugmakers are required to ensure by regulators on both sides of the Atlantic. The award also means that the firm has agreed to undergo recertification audits every three years as well as annual surveillance visits.
Burghard Freiberg, Senior VP, Pharmaceutical Chemicals Solutions at EMD Millipore predicted the "audit will assure our customers they are incorporating only the highest quality excipients into their formulations and we have minimized risk in their supply chain."
He added that: “We encourage all manufacturers of excipients to undergo the same audit."
This was echoed by Matthias Bucerius, director of pharmaceutical raw materials at the firm, who said: "Collaborating with the Excipact association to execute this audit was an important step for our company and our customers.”
EMD Millipore’s enthusiasm is only to be expected given that it has just passed and that it was one of several firms – including BASF, Croda, Pfizer and SGS – present at the scheme's launch in Barcelona, Spain in January last year.
Neither EMD Millipore nor its parent company – German drugmaker Merck KGaA – was able to respond to in-Pharmatechnologist.com’s request for more information ahead of publication.