EDQM publishes draft General Chapter “Quality of Data” for Comments

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a draft version of General Chapter 5.38 “Quality of Data,” which is now open for public review and can be commented on until 31 December 2024.

Impact of Technological Advancements

The draft of the new chapter refers to data generated, collected, stored, or used in the context of experimental analyses performed by quality control (QC) laboratories and highlights their increasing importance in relation to the quality assessment of medicines, particularly when these data are fed into numerical models based on chemometrics, machine learning (ML), or other forms of artificial intelligence (AI) in order to make inferences, make decisions and take action.

In this context, a defined quality standard must be applied and ensured.

Scope 

The purpose of this chapter is to focus on the “raw material” of data analysis, providing an overview of applicable data quality concepts, describing best practices for achieving a sufficiently high data quality, and reporting a summary of data governance procedures.

Quality of Data 

The text defines data as a collection of values, as “data elements” or “unit of data” with specific meaning derived from its context, including the source and generation processes.

Data elements can be classified into:

• Primitive types (e.g., Boolean, , integers, real values, characters)
• Composite, structured types (e.g., arrays, tables)
• Unstructured types, not following a predefined format (e.g., text documents, natural language)

You can view and comment on the draft of chapter “5.38. QUALITY OF DATA” at: https://pharmeuropa.edqm.eu/home.