Sigma-Aldrich Life Science & Technology site in Wuxi, PR China, has recently been awarded an EXCiPACT GMP Certificate from Bureau Veritas, one of EXCIPACT’s internationally-recognised Certification Bodies.
The certificate demonstrates that this site manufactures pharmaceutical excipients according to the EXCiPACT GMP Certification Standard. Its scope covers the testing and packaging for organic and inorganic salts, organic and inorganic acids and bases used as pharmaceutical excipients.
Both Bureau Veritas and their auditors had to undergo a rigorous assessment process in order to be EXCiPACT Registered. Both have satisfied the additional EXCiPACT competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021-1:2015 standard. These include completion of the 2-day EXCiPACT Auditor Training Course, post-course written examination and independently witnessed audit to verify their competency to the required standard. Bureau Veritas also had to have their auditor’s report verified by their independent certification board prior to issuing the certificate.
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or commission third-party physical risk-assessment audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden.
However, using GMP and GDP standards designed specifically for pharmaceutical excipients, the voluntary, 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 product quality.
