Charles River Shanghai Receives OECD Certification First preclinical contract research organization in China to receive certification
WILMINGTON, Mass., Apr 15, 2010 (BUSINESS WIRE) --Charles River Laboratories, Inc. (NYSE: CRL), today announced the Company's Shanghai facility became the first preclinical laboratory in China to receive a Certificate of Good Laboratory Practice (GLP) compliance from an Organization for Economic Cooperation and Development (OECD) member country. The certificate acknowledges the site is operating in compliance with OECD Principles of GLP for both toxicology and laboratory services.
The one-week inspection was conducted by the Belgian national GLP compliance monitoring authority. In addition to an extensive facility assessment, the inspection included an audit of three completed and two on-going studies. The facility inspection evaluated key operations areas including: vivarium rooms, pharmacy, analytical chemistry, bioanalytical chemistry, clinical pathology, and histopathology.
After a thorough audit of the facility, the Belgian national GLP compliance monitoring authority certified that Charles River's Shanghai facility is operating in compliance with OECD Principles of Good Laboratory Practice. "The facility has best practices in place for conducting GLP studies which are supported by sophisticated systems and a well organized site," said Mr. Guido Jacobs, GLP Inspector, Belgium Government Scientific Institute of Public Health, Bureau of Quality Assurance.
"Our China facility was established on the premise that we would provide our clients with the same high standards of research, safety, animal welfare and good laboratory practices that distinguish Charles River," said James C. Foster, Chairman, President and Chief Executive Officer of Charles River. "As the first preclinical CRO to receive a Certificate of Compliance from an OECD member country, Charles River is distinctively positioned to help our clients develop IND-enabling programs at our Shanghai facility. This certification marks a significant milestone in our commitment to strategically partner with our clients globally to accelerate their drug development programs."
Charles River's Shanghai facility has also received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC). Additional details of these regulatory milestones are outlined in the press release "Charles River Shanghai Facility Receives AAALAC, CCAC and SLAC Accreditations."
About Charles River
Accelerating Drug Development. Exactly. Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our approximately 8,000 employees worldwide are focused on providing clients with exactly what they need to improve and expedite the discovery, development through first-in-human evaluation, and safe manufacture of new therapies for the patients who need them.
About Organization for Economic Cooperation and Development (OECD)
The OECD Principles of GLP set out managerial concepts covering the organization of test facilities and the conditions under which pre-clinical safety studies are executed. Their purpose is to ensure the generation of high quality and reliable test data (in vitro and in vivo) related to the safety of chemicals and preparations in the framework of the Mutual Acceptance of Data (MAD).
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This position is responsible for serving as a as a study director (SD), project scientist (PS) and/or principal investigator (PI) in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research; coordinating all phases of the study planning process with appropriate departments; generating high-quality project plans, protocols, amendments and reports appropriate for assigned studies; reviewing, interpreting, integrating and presenting data on assigned studies; and functioning as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
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