Compliance Statements and Certifications

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 of Compliance.  These Statements of Compliance indicate that the laboratory has been inspected and found to be in compliance with GLPs.  Charles River Laboratories facilities located in Canada, Ireland, and the United Kingdom are subject to GLP monitoring by the European Agency for the Evaluation of Medicinal Products (EMEA), the Irish National Accreditation Board (INAB), and the Medicines and Healthcare products Regulatory Agency (MHRA), respectively.  These GLP monitoring authorities issue Statements of Compliance.  The following Statements of Compliance reflect the current status of the Charles River Laboratories facilities operating in those countries mentioned above.

  Statement of GLP Compliance - Canada

  Statement of GLP Compliance - Edinburgh

  Statement of GLP Compliance - Ireland

  Certificate of GMP Compliance - Human Medicinal Products - Ireland

  Certificate of GMP Compliance - Veterinary Medicinal Products -
        Ireland

  Animal Welfare Certification (April 2008) for Charles River
        Laboratories Preclinical Services Ireland, Ltd.

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