Qualicaps Europe, S.A.U. site receives EXCiPACT GMP certification as pharmaceutical excipient suppliers
BRUSSELS, 13 February 2018
EXCiPACT asbl is delighted to announce that the Qualicaps Europe’s site in Alcobendas (Madrid) has recently been awarded an EXCiPACT Certificate from AENOR, one of EXCIPACT’s internationally-recognised Certification Bodies.
The Certificate demonstrates that the Qualicaps Europe’s site in Alcobendas, Madrid, Spain, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers manufacture of gelatin and hypromellose capsule shells for the pharmaceutical and consumer health industries. For full details of all sites that have been EXCiPACT certified to date in 15 Countries (Canada, China, Belgium, France, Germany, India, Israel, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA), see http://www.excipact.org/certificate-holders.html.
Both AENOR and their auditors had to undergo a rigorous assessment process in order to be EXCiPACT Registered. This required the 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. AENOR also had to have their auditor’s report verified by an independent certification board prior to issuing the certificate.
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or commission 3rd party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden. Using GMP and GDP standards designed for excipients, the independent, high quality 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.