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STAR-TECH & JRS SPECIALTY PRODUCTS CO., LTD CHINESE SITE RECEIVES
- Publisher：
- Publication time：2017/6/9
STAR-TECH & JRS SPECIALTY PRODUCTS CO., LTD CHINESE SITE RECEIVES
EXCiPACT GMP CERTIFICATION AS PHARMACEUTICAL EXCIPIENT
SUPPLIERS
Brussels, 08 June 2017
EXCiPACT asbl is delighted to announce that the Star-Tech & JRS Specialty Products Co., Ltd Chinese site has
recently been awarded an EXCiPACT Certificate from BV China, one of EXCIPACT’s internationally-recognised
Certification Bodies.
The Certificate demonstrates that the Star-Tech & JRS Specialty Products Co., Ltd site in Changsou District,
Chongqing, China manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing
Practice (GMP) Certification Standard. Its scope covers manufacture of Povidone, Crospovidone and
Copovidone. For full details of all sites that have been EXCiPACT certified to date in 15 Countries (Canada,
China, Belgium, France, Germany, India, Israel, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The
Netherlands, UK and USA), see http://www.excipact.org/certification/certificates/
Both BV China and their auditors had to undergo a rigorous assessment process in order 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. BV China also had to have their auditor’s report verified by an independent certification board prior
to issuing the certificate.
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or commission
3rd 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 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their
audit burden, save costs and assure quality.
Notes for the Editor
EXCiPACT asbl provides management oversight for a high quality, voluntary international EXCiPACT Certification Scheme that provides
for independent 3rd party GMP and/or GDP certification of manufacturers, suppliers and distributors of pharmaceutical excipients
worldwide. The Scheme will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient
supply chain. It has been operational since early 2013 since when there has been considerable interest among pharmaceutical excipient
suppliers, customers and regulators. For further information see www.excipact.org or contact info@excipact.org.
EXCiPACT is a registered trademark.
EXCiPACT GMP CERTIFICATION AS PHARMACEUTICAL EXCIPIENT
SUPPLIERS
Brussels, 08 June 2017
EXCiPACT asbl is delighted to announce that the Star-Tech & JRS Specialty Products Co., Ltd Chinese site has
recently been awarded an EXCiPACT Certificate from BV China, one of EXCIPACT’s internationally-recognised
Certification Bodies.
The Certificate demonstrates that the Star-Tech & JRS Specialty Products Co., Ltd site in Changsou District,
Chongqing, China manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing
Practice (GMP) Certification Standard. Its scope covers manufacture of Povidone, Crospovidone and
Copovidone. For full details of all sites that have been EXCiPACT certified to date in 15 Countries (Canada,
China, Belgium, France, Germany, India, Israel, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The
Netherlands, UK and USA), see http://www.excipact.org/certification/certificates/
Both BV China and their auditors had to undergo a rigorous assessment process in order 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. BV China also had to have their auditor’s report verified by an independent certification board prior
to issuing the certificate.
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or commission
3rd 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 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their
audit burden, save costs and assure quality.
Notes for the Editor
EXCiPACT asbl provides management oversight for a high quality, voluntary international EXCiPACT Certification Scheme that provides
for independent 3rd party GMP and/or GDP certification of manufacturers, suppliers and distributors of pharmaceutical excipients
worldwide. The Scheme will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient
supply chain. It has been operational since early 2013 since when there has been considerable interest among pharmaceutical excipient
suppliers, customers and regulators. For further information see www.excipact.org or contact info@excipact.org.
EXCiPACT is a registered trademark.