27/28 November 2019
For a long time now, the FDA has been investigating data integrity within pre-approval inspections. According to FDA's document No 7346.832 on pre-approval inspections, data integrity has to be reviewed during an FDA inspection.
To verify compliance with the CMC section of the marketing authorisation, an FDA inspection will perform a "Data Integrity Audit" by means of the following examples:
In January 2014, the MHRA declared that as of 2014, pharmaceutical facilities will be expected to verify data integrity in the context of self inspections. The performance of periodical self inspections is required by Chapter 9 of the EC GMP Guide.
To find out more please see the MHRA Expectation regarding Self Inspection and Data Integrity.
Source: MHRA, UK and FDA, USA