IGMPI India

Inspection trend data report from 2013 have been published by MHRA which also includes longer term trends in top 10 deficiencies and highlight areas for continued focus.

Prevalently observed deficiencies were related to "Quality Systems" during inspections. Following was the trend with major and critical on deficiencies over the last five years:

1   Major observations remained constant
2   Due to a cluster of data integrity issues with potential impact to public health, there was increase in critical      observations per inspection which remained constant until 2013.
3   Relative number of critical observations per inspection were high in Asia as compared to other continents

The reorganization will have major impact on all the inspections carried out by FDA in terms of its efficiency improvement of enforcement studies.