Swiss site granted GMP certificate for excipient gases

Published: 15-Mar-2017

The Carbagas Domdidier site has received GMP certification from EXCiPACT as pharmaceutical excipient suppliers

Swizz providers of gases for industrial and healthcare industries, Carbagas, has been awarded an EXCiPACT Certificate for its site in Domdidier, to manufacture excipients.

Its scope covers filling of pharmaceutical grade gases, nitrogen, oxygen, argon, carbon dioxide, in cylinders and bundles.

To demonstrate GMP or GDP compliance, EU and US pharmaceutical regulations require drug manufacturers to conduct, or commission 3rd party, physical audits of all their starting material suppliers.

The GMP process

The 3rd Party EXCiPACT Certification Scheme helps excipient users and suppliers to reduce their audit burden to save costs.

AJA is one of EXCIPACT’s Certification Bodies. AJA certified Carbagas; their auditor’s report was then verified by an independent certification board prior to issuing the certificate.

Both AJA and their auditors had to undergo an assessment process to be EXCiPACT Registered, requiring successful completion of the EXCiPACT Training Programme and post-course examination, followed by an independently witnessed audit to verify that their competency was to the required standard.

You may also like