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Abstract

This study presents findings from Good Laboratory Practice (GLP) inspections in Japan. In Japan, GLP inspections of facilities that test pharmaceuticals and medical devices are coordinated by the Office of the Conformity Audit of the Pharmaceuticals and Medical Devices Agency (PMDA). All of the applications received for GLP inspection by the PMDA from fiscal years (FY) 2009 to 2011 were reviewed. The article analyzes the VAI (Voluntary Action Indicated) recommendations that were made to the test facilities after inspection. Using these data sources, the study calculates the number of VAI recommendations made to the facilities, classifies the topics of notification, and demonstrates trends in the VAIs issued in FY2011. In FY2011, the number of VAI issues about animal care and management as well as computerized systems increased compared with FY2009 and FY2010.

Keywords

Good Laboratory Practice (GLP)Pharmaceuticals and Medical Devices Agency (PMDA)GLP inspection regulation nonclinical safety studies

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References

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Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011

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