Consequences of the new MHRA Guideline for Excel

Recommendation
10/11 September 2025
MS Excel is used in analytical laboratories for many purposes - for example for calculations, and frequently also for the storage of data. For electronically stored data, there have been requirements since the formation of the EU GMP Guide. They are defined in Chapter 4 (Documentation) and in the complementary Guideline (Annex 11), which both have been revised a few years ago. This year (in March 2015), the British MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). Please also see the GMP news from February 2015 with regard to the new MHRA Guideline and from April 2015 relative to the short-term revision of the MHRA Guideline for data integrity.
These requirements apply to all electronically stored data - regardless of the technology used. Therefore, they also apply to data stored in Excel. MS Excel alone has not the functionality required for ensuring the integrity and transparency of stored data. For saving GMP-relevant data in Excel files both additional organizational measures (e.g. procedures) AND appropriate tools (e.g., document management systems, VBA, or commercial Excel extensions) are needed. That way, GMP compliance can also be accomplished for data saving Excel applications.
Related GMP News
14.07.2025Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter
14.07.2025EMA publishes new Product-Specific Bioequivalence Guidance
14.07.2025Revision of USP Chapter <1039> Chemometrics Published for Comments
14.07.2025Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers
14.07.2025New USP Chapter <1221> on Ongoing Procedure Performance Verification (OPPV) Published for Comment
02.07.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls