Laboratory Services

GLP Compliance Auditing

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Any non-clinical laboratory facility you use to conduct safety and toxicology testing in animals may be subject to inspection by FDA, EPA, or other regulatory bodies. We can prepare you by performing independent audits of sponsor or contract facilities and studies, giving you additional assurance that a lab is in compliance with regulations (e.g., 21 CFR 58) and SOPs. Should deficiencies be identified, Courant auditors can also recommend remedial actions.

 

GLP Study Audits

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• Review protocol and compliance to protocol

• Review SOP and compliance to procedures

• Perform in-process study inspections

• Conduct data reviews

• Conduct reviews of draft and final reports

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GLP Vendor Audits

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• Perform routine and qualification audits of contract laboratories

• Inspect facilities and equipment

• Review organization structure and SOP content

• Assess qualification and training of personnel

• Asses testing facilities operation, including test and control articles

• Review records, reports, and record/sample retention

• Assess the data transfer process

• Assess Quality systems