National Good Laboratory Practice (GLP) compliance monitoring authorities document the compliance status of nonclinical laboratories in different ways. The United States Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) document the compliance status of laboratories through inspection reports and post-inspectional correspondence. These documents are available from the respective agencies under the Freedom of Information Act. The FDA also maintains a historical list of nonclinical laboratory inspections that provides the agency’s classification of each inspection.
Many monitoring authorities outside the United States document the compliance of laboratories by the issuance of Statements or Certificates of Compliance. These Statements of Compliance indicate that the laboratory has been inspected and found to be in compliance with GLPs or GMP (Good Manufacturing Practice). Charles River facilities located in Canada, Ireland, Germany, and the United Kingdom are subject to GLP or GMP monitoring by the European Agency for the Evaluation of Medicinal Products (EMEA), the Irish National Accreditation Board (INAB), the Bezirksregierung and the Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz NRW (Germany)and the Medicines and Healthcare products Regulatory Agency (MHRA), respectively. These GLP and GMP monitoring authorities issue Statements of Compliance. The following Statements or Certificates of Compliance reflect the current status of the Charles River facilities operating in those countries mentioned above.
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The Charles River Animal Welfare department has made recent strides in further integrating the 3Rs into our operations. Charles River representatives are acting as ambassadors within the industry to elevate the importance of animal welfare in laboratory animal research
Through this agreement, Charles River will sell the Axcess™ System, an offering that combines the Bruker MALDI Biotyper system with a custom data analysis software solution that allows instantaneous access to the Accugenix® microbial database for identifications.
Jun 22–Jun 26
Founded in 1960, the Teratology Society is a multidisciplinary society drawing its members from academia, industry and government. In addition to being an exhibitor, Charles River is pleased to be a platinum level sponsor and to be participating in this year’s meeting with multiple posters presentations.
May 21–May 24
RDD Europe 2013 is a forum for pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise.
May 23–May 23
This full-day seminar encompasses selected topics from our Charles River Short Course on Laboratory Animal Science. We would like to acknowledge Michigan State University for hosting this event and extend our heartfelt thanks to guest speaker Dr. Danielle Ferguson.
This position is responsible for managing international aspects of US Federal income tax compliance; assisting with international tax planning, including identification of planning opportunities, designing and implementing plans, and transfer pricing process; overseeing quarterly ETR forecast process; and participating in the tax provision process, including assessment of tax risks, documentation of key positions, and review of non-US tax provision submissions.
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.
Charles River Laboratories, Inc.