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FDA Revised Inspection Guide April 18, 2011

Posted by Michael Hamrell in Regulatory Thoughts.

The FDA has published an update to the Compliance Program Guidance Manual on the conduct of inspections of Sponsors/Monitors and CROs (CPGM 7348-810).  This is the first revision to this inspection manual since it was last updated in February 2010.  The basic inspection program has not changed, but there are several new considerations for the inspection.  The Manual instructs the Inspector to pay closer attention to the collection of investigator’s financial disclosure information, the company’s reporting of the study to clinicaltrials.gov, and the use of international data and the review of the study records.  There are also some revisions and updates to the oversight of the use of electronic records and electronic signatures.  As computerized systems become a bigger and bigger part of clinical trials, it is not surprising that this has received more attention.  Finally, the revised Guidance Manual gives the inspectors more detailed instructions on documenting violations, especially those that may involve fraud.



1. GxP Perspectives - April 20, 2011


I was also struck by the new Compliance Program Guidance Manual’s giving instructions about reviewing GLP studies during a GCP sponsor inspection. I have heard several times of this coming up in a sponsor inspection in the past year or two. The agency is making it clear that it does not like draft final reports in an NDA.


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