compliance statements and certifications
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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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Good Laboratory Practice, GLP compliance, Statements of Compliance, FDA, EPA, European Agency for the Evaluation of Medicinal Products, EMEA, Irish National Accreditation Board, INAB, Medicines and Healthcare products Regulatory Agency, MHRA
GLP/GMP Compliance Statements and Certifications for Charles River Facilities
GLP/GMP Compliance Statements and Certifications for Charles River Facilities Worldwide