Consequences of the new MHRA Guideline for Excel

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

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.