Navigation Links
WuXi AppTec Bioanalytical Services Unit Passes FDA Inspection
Date:3/31/2009

SHANGHAI, March 31 /PRNewswire-Asia/ -- WuXi AppTec announced today that its Bioanalytical Services (BAS) unit had been inspected by the U.S. Food and Drug Administration (FDA) without the issuance of a Form 483, which is used to report any non compliance issues after a site inspection.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040705/CNM002LOGO )

WuXi's Bioanalytical Services (BAS) was established in 2005. BAS provides Good Laboratory Practice (GLP)-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to measure biomarker/biologics and antibody immunogenicity using immunochemistry.

In the FDA review, which took place between March 23 and March 27, the entire BAS facility was inspected and two bioequivalency (BE) studies were audited. The State Food and Drug Administration (SFDA) of China sent four investigators to participate as observers.

"We are very pleased to have passed this audit," commented Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec. "It represents our company's first audit by U.S. FDA and the first such audit of any bioanalytical laboratory in China. WuXi will continue to pursue the highest levels of quality and transparency to meet and exceed FDA requirements."

"As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Executive Director of BAS of WuXi AppTec. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."

"Quality is our watchword, and continuous improvement in quality is the foundation of our success," echoed Mr. Robert Coldreck, Vice President of GLP Quality Assurance of WuXi AppTec.

About WuXi PharmaTech and WuXi AppTec

WuXi PharmaTech (NYSE: WX) is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec. For more information, please visit: http://www.wuxiapptec.com .

    For more information, please contact:

     Sherry Shao
     WuXi PharmaTech (Cayman) Inc.
     Tel:   +86-21-5046-4002
     Email: pr@wuxiapptec.com

'/>"/>
SOURCE WuXi PharmaTech (Cayman) Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. WuXi AppTec Successfully Holds Its 2009 Supplier Conference in Shanghai
2. Lutheran Senior Services Partners with Silverchair Learning Systems to Enhance Employee Training and Education
3. GAO Report Confirms: Medicare Underpays for Anesthesia Services; Nurse Anesthetists Assure Seniors Access to Safe Anesthesia Care
4. Therap Services Continues to Hire Experienced Developmental Disability Industry Clinicians for its Customer Support Team
5. Tata Consultancy Services to Support Roches Global Capacity Building Initiative
6. Creative Technology Services Enhances its Global Competitiveness with Additional Regulatory Certifications
7. Medical Services International Maintains Pace in Second Quarter
8. Area Health Care Providers Announce Plans to Integrate Services
9. Crdentia Selected by High Rock Raceway to Provide Healthcare Staffing Services
10. Award-winning QUITPLAN(R) Services Billboard Debuts in Rogers
11. AMN Healthcare Services to Host Analyst Day on Tuesday, September 18, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
(Date:10/12/2017)... ... 2017 , ... The American College of Medical Informatics (ACMI) will present the ... Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... a pioneer in the field of medical informatics, this prestigious award is presented to ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare events ... Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the ... The annual award competition recognizes editorial and design excellence across a range of sectors. ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host its fiscal ... Friday, November 3, 2017, beginning at 7:00 a.m. (CDT) ... a.m. (CDT) / 9:30 a.m. (EDT). In ... guidance for 2018, Hill-Rom executives will also highlight the ... long-range financial outlook through 2020. ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology: