Muenster-based audit firm Blue Inspection Body (Blue) has been registered by Excipact as a certification body for excipients used in the production of pharmaceuticals
Norbert Waldöfner, lead auditor, blue
This is conditional upon accreditation according to DIN EN ISO/IEC 17021, which Blue received in December 2015.
The Excipact industry initiative provides a certification scheme for the independent monitoring of good manufacturing practices (GMP) and good distribution practices (GDP) of excipients.
Blue was accredited as the first provider of GMP audits for active pharmaceutical ingredients in Europe according to DIN EN ISO 17020 as early as 2008.
Since 2012, Blue has also conducted GMP audits for pharmaceutical excipients.
Instead of having to organise their own monitoring visits to manufacturers of pharmaceutical excipients, pharmaceutical companies have been able to use the Excipact third-party audit reports for some time now, according to Blue.
Norbert Waldöfner, lead auditor of Blue, said: “The new procedure represents a sensible alternative and qualitative improvement to the purely client-specific audits carried out.”
The initiative qualifies independent third-party auditors, who monitor excipient production according to the strict Excipact standard.
Waldöfner said: “The Excipact system provides for fewer audits, but for audits going into significantly greater depth.
“This ensures that the corresponding GMP requirements are consistently implemented during excipient production.”