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The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
This week, the first EXCiPACT Certificate in China was awarded to Boai NKY Pharmaceuticals Ltd., by Bureau Veritas Hong Kong. This certification demonstrates that Boai NKY Pharmaceuticals Limited’s site in Jiaozuo, Henan Province, China, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) certification standard. This is the first Chinese site to receive EXCiPACT Certification, and is the twenty third global site to be certified to EXCiPACT so far.
EU and U.S. 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. Various organizations offer third-party certification services, which are designed to help excipient users and suppliers save the time and cost required for audits, and assure quality. New EU guidelines require auditing be done by March 21, 2016. Currently, industry observers have pointed out, many companies have not yet done this.