BCN Trasvases receives ExciPact GMP certification at Spanish plant
The facility in Barcelona manufactures excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard
BCN Trasvases facility in Spain has earned an EXCiPACT certificate from Aenor, one of EXCIPACT’s internationally-recognised Certification Bodies.
The certificate demonstrates that BCN Trasvases' site in Santa Perpetua de Mogoda, Barcelona, Spain, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the packaging of calcium carbonate to be used as a pharmaceutical excipient.
To be EXCiPACT registered, both Aenor and its auditors had to undergo a rigorous assessment process. 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 its auditor’s report verified by an independent certification board prior to issuing the certificate.
EU and US pharmaceutical regulations now require drug manufacturers to conduct either their own or commission third party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance. Using GMP and GDP standards designed for excipients, the EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.