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Data Integrity: New Focus area for GMP inspections - 12 Mar 2015

There has been an increasing interest in the area of data integrity from the regulatory authorities.  For instance, the MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self-inspections.   And In recent years, the number of complaints in FDA Warning Letters with regard to data falsification and fraud – especially in analytical GMP laboratories regarding the use of chromatography data systems (CDS) – has witnessed an increasing surge.

Both the UK MHRA and the US FDA have published guidelines on this subject matter of data integrity.  The UK MHRA Guideline on data integrity was published in January 2015.  According to the MHRA, data integrity in a pharmaceutical quality management system is fundamental to ensure that the medicinal products are of the quality expected.   The Guideline describes MHRA's expectations for data in the GMP environment of pharmaceutical companies.   Similarly, the US FDA has set out in its Compliance Programme Guide (CPG) 7346.832 the requirements for audits of data integrity during FDA Pre-Approval inspections.  In addition, FDA's inspectors have been explicitly trained on computer systems and the data they contain. 

These requirements complement the existing regulations of the GMP regulations (Eurdralex Volume 4 and 21CFR).  Although the MHRA requirement does not expect a forensic approach to data checking, it however expects that a system should be developed and run which gives an acceptable state of control based on the data integrity risk.  The requirements apply to both manual (paper) and electronic data.  The system should be fully documented with a supporting rationale.

For further information please see the MHRA's complete document (15 pages) GMP Data Integrity Definitions and Guidance for Industry January 2015.

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