The European Pharmacopoeia (Ph. Eur.) has published a new general chapter on Quality of data (5.38) in Issue 12.3, following its adoption by the European Pharmacopoeia Commission at its 182nd session in June 2025.
Published for information, this chapter addresses the quality of data, with a particular focus on data of digital origin. It complements existing Ph. Eur. chapters that support digital and technological transformation in the pharmaceutical sector, namely Chemometric methods applied to analytical data (5.21), Multivariate statistical process control (5.28), Design of experiments (5.33), Chemical imaging (5.24) and Process analytical technology (5.25).
Key highlights
General chapter 5.38 provides a framework for managing digital data quality across its entire life cycle. It introduces:
- general concepts of data, data governance and quality dimensions, such as accuracy, bias, completeness and reproducibility;
- the Extract-Transform-Load (ETL) process as a framework for managing data throughout its life cycle;
- the role of subject matter experts (SMEs) in ensuring data is fit for purpose, especially when used in automated decision-making systems;
- an overview of data sources (e.g. sensors, databases and cloud platforms) and data formats for storage, including open formats.
This new chapter is a significant step in the Ph. Eur.’s adaptation to the evolving digital landscape, ensuring that data used in decisions concerning pharmaceutical quality is robust, reliable and well-governed.
Ph. Eur. Issue 12.3 has just been released on the European Pharmacopoeia Online platform. Texts published in this issue will come into force on 1 July 2026.
See also: