QUALITY_ASSURANCE

 

 

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ITR Management is committed to a high level of scientific quality and regulatory compliance. A single quality standard is operated within the entire facility and this standard is Good Laboratory Practice (GLP). Compliance is based on the following regulatory agencies:

 

articlelistarrow3 The United States Food and Drug Administration (FDA)
articlelistarrow3 Organization for Economic Cooperation and Development (OECD)
articlelistarrow3 Japanese Ministry of Health, Labor, and Welfare (MHLW)

 

At ITR the Quality Assurance (QA) Department monitor GLP studies to ensure compliance with Good Laboratory Practice (GLP) Regulations. QA personnel remains independent of the studies and are not involved in study activities.

 

QA inspect critical phases of studies for compliance with the protocol, the standard operating procedures and the GLP regulations. In addition QA conduct inspections of study raw data and reports. The findings of the inspections are reported to the Study Director and Management and a Quality Assurance statement is provided for the report.

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