The first site in the US to receive EXCiPACT certification, its scope covers the production, testing and packaging of PVP and PVPP
EXCiPACT is delighted to announce that Ashland Specialty Ingredients ISP Chemicals has recently been awarded an EXCiPACT certificate from SGSICS France, one of EXCIPACT’s internationally recognised certification bodies.
The certificate demonstrates that the Ashland site in Calvert City (Kentucky, USA) manufactures pharmaceutical excipients according to the EXCiPACT good manufacturing practice (GMP) certification standard.
This is the first site in the US to receive EXCiPACT certification. Its scope covers the production, testing and packaging of PVP and PVPP used as pharmaceutical excipients.
Both SGS ICS France and their auditors had to undergo a rigorous assessment process 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.
SGS also had to have their 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, thus increasing the audit burden. Using GMP and GDP standards designed for excipients, the new, high quality third party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.