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Services - GLP/ GLCP

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GLP Study Audits

• 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
• 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 QA unit

 

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