Nanjing Duoyuan Biochemistry receives EXCiPACT GMP certification

Published: 29-Jul-2016

Company certified to produce pharmaceutical grade lanolin

EXCiPACT is delighted to announce that the Nanjing Duoyuan Biochemistry’s Chinese site has recently been awarded an EXCiPACT certificate from SGS, one of EXCIPACT’s internationally recognised certification bodies.

The certificate demonstrates that the site in Nanjing City, Jiangsu Province, China, manufactures pharmaceutical excipients according to the EXCiPACT good manufacturing practice (GMP) certification standard.

Both SGS and its 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 its auditor’s report verified by an 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 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 independent, high quality third party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.

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