St. Paul and Atlanta Laboratories of WuXi PharmaTech (NYSE:WX) Receive ISO/IEC 17025:2005 Accreditat
Jan 12, 2009
January 12, 2009 – Shanghai, China – WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that its testing laboratories in St. Paul and Atlanta had recently received ISO/IEC 17025:2005 accreditation for technical competence in the field of biological testing for a defined scope of operations, including biocompatibility testing and microbiology. The accreditation was received from the American Association for Laboratory Accreditation, which conducted a review and field audit of both sites using personnel with expertise specific to the kinds of testing these sites perform.
ISO standards are set by the International Organization for Standardisation (ISO), a network of national standards institutes of 157 countries. The International Electrotechnical Commission (IEC) creates standards for applications in electricity, electronics, and related fields. These standards cover a wide range of industries and are based on authoritative international practice. ISO/IEC 17025 standards for which the accreditation was recently achieved in St. Paul and Atlanta specifically cover the competence requirements of testing and calibration laboratories.
To obtain this accreditation, the laboratory must demonstrate competence in both management and technical requirements. Management requirements cover the effective operation of a quality management system. Technical requirements relate to the competence of staff, the correctness of testing methodologies, the adequacy of equipment, and the accuracy of results. To obtain accreditation, the laboratory must submit to a thorough review of its processes and procedures, including observation of actual testing being undertaken. The lab must make use of the latest scientific and technical knowledge, conduct internal audits, demonstrate continual improvement, and communicate effectively with customers. WuXi's ISO/IEC 17025:2005 accreditation is for a renewable two-year period.
"Receiving ISO/IEC 17025 accreditation is further demonstration of the quality of our laboratory testing and the competence of our technicians," said Edward Hu, Chief Operating Officer. "We initially sought conformity to ISO/IEC 17025:2000 standards (issued in 2000) at the specific request of a medical device client. We proactively pursued accreditation to ISO/IEC 17205:2005 standards (issued in 2005) to continue satisfying our valued customers. The company's responsiveness not only satisfied a valued customer, but it also now equips WuXi PharmaTech with a credential it will use to demonstrate to new and existing clients that our testing procedures meet the highest standards of excellence. Few of our competitors have ISO/IEC 17025 accreditation."
About WuXi PharmaTech (Cayman) Inc.
WuXi PharmaTech 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 pharmaceutical, biotechnology and medical device companies 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. The operating subsidiaries of WuXi PharmaTech are known as WuXi AppTec. For more information, please visit: www.wuxiapptec.com.