Data Integrity - MHRA's Current Expectations

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

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:

• Verification of the accuracy and completeness of the data in the CMC section,
• The inspector may select key data sets or randomly select data,
• Data on finished product stability, dissolution, content uniformity, and impurity are generally audited,
• Comparison of raw data (hardcopy or electronic) such as chromatograms, spectrograms, laboratory analyst notebooks, etc.,
• In case of deviations from the data integrity, the inspector has to clarify who is responsible for the entry or non-entry of certain data in the marketing authorisation application.

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