SHANGHAI, Feb. 28, 2017 /PRNewswire/ -- WuXi AppTec, a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, today announced that its Lab Testing Division(LTD)'s Bioanalytical facility in Shanghai once again passed US FDA's bioequivalence (BE) inspection with no 483 observations.
The inspectors from FDA thoroughly audited WuXi's quality system during the 5-day inspection, focusing on scientific data integrity, operation infrastructure, equipment, sample storage, archival system, quality control, and quality assurance. The inspection covered two bioequivalence studies for pre-approval including method validation and sample analysis and eight other clinical bioanalytical studies from 2013 and 2016 as a general regulatory compliance inspection.
"FDA has the most stringent requirement on quality and data integrity among international regulatory agencies. We are proud with the result of this audit," says Dr. Jason Liu, Senior Vice President and Chief Operating Officer of Lab Testing Division. "We will continue to maintain the highest quality standards, and provide the best-in-class R&D services for our customers worldwide."
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated." Please visit http://www.wuxiapptec.com
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The inspectors from FDA thoroughly audited WuXi's quality system during the 5-day inspection, focusing on scientific data integrity, operation infrastructure, equipment, sample storage, archival system, quality control, and quality assurance. The inspection covered two bioequivalence studies for pre-approval including method validation and sample analysis and eight other clinical bioanalytical studies from 2013 and 2016 as a general regulatory compliance inspection.
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"FDA has the most stringent requirement on quality and data integrity among international regulatory agencies. We are proud with the result of this audit," says Dr. Jason Liu, Senior Vice President and Chief Operating Officer of Lab Testing Division. "We will continue to maintain the highest quality standards, and provide the best-in-class R&D services for our customers worldwide."
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated." Please visit http://www.wuxiapptec.com
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SOURCE WuXi AppTec
