The pharmaceutical excipient supplier has been awarded the certificate for its site in Greenwood, US
EXCiPACT asbl has announced that the Capsugel (now a Lonza company) site in Greenwood, South Carolina, US has recently been awarded an EXCiPACT GMP certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies. The certificate demonstrates that the site manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the manufacturing of empty hard capsules for use as a pharmaceutical excipient.
Both SGS and their auditors had to undergo a rigorous assessment process in order to be EXCiPACT Registered. Both satisfied the additional EXCiPACT competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021-1:2015 standard. Their auditors successfully completed the two-day EXCiPACT Auditor Training Course and post-course written examination followed by an independently witnessed audit to verify that their competency was to the required standard. SGS' auditor’s report was verified by an independent certification board prior to the certificate being issued.
For full details of all sites that have been EXCiPACT certified to date in 16 countries (Canada, China, Belgium, France, Germany, India, Israel, Italy, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and US), see www.excipact.org/certificate-holders.html.
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or commission third-party physical audits of their starting material suppliers to demonstrate GMP and/or GDP compliance, therefore increasing the audit burden. However, using GMP and GDP standards designed specifically for pharmaceutical excipients, the independent, high quality EXCiPACT Certification Scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, to reduce their audit burden, to save costs and to assure quality.