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GMP News

18.12.2025

FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books

Excel spreadsheets remain widely used in GMP-regulated environments, but without adequate controls they pose significant data integrity risks. This news item refers to an FDA Form 483 in which investigators identified fabricated Excel-based production records, deleted electronic files, and duplicate log books, highlighting the importance of robust spreadsheet governance for GMP-compliant data integrity systems.

18.12.2025

Questions and Answers on System Suitability Tests (SST) - Part 1

During the ECA Live Online Training “System Suitability Tests (SST) and Troubleshooting for HPLC Methods” on 04 November 2025, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing by the speakers’ team after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As. Read Part 1 here.

18.12.2025

PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!

PharmaLab 2025 took place from 24 to 26 November in Neuss, featuring nine parallel conferences and two pre-conference workshops with more than 100 presentations. This year, the ECA Analytical Quality Control Group (AQCG) organised a one-day conference track entitled “Analytical Quality and Lifecycle Concepts”. Moderated by Dr Christopher Burgess (AQCG Chairman), the track comprised a series of presentations and discussions.

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