EDQM publishes New Chapter "Quality of Data" for Comments
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The draft of the new chapter "5.38. QUALITY OF DATA" has been published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) in the Pharmeuropa section and can be commented on until 31 December 2024, along with several other new drafts.
The draft of the new chapter refers to data that is generated, collected or used in the context of quality control and highlights its increasing importance in relation to the quality assessment of medicinal products. In particular, if this data is processed or read out using AI (artificial intelligence) and/or ML (machine learning), it is necessary to apply and guarantee a defined quality standard. To this end, the draft of the new chapter sets out specifications and definitions in six sections and several subsections.
You can view and comment on the draft of chapter "5.38. QUALITY OF DATA" on the Pharmeuropa website after registering once.
Related GMP News
18.12.2025FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books
18.12.2025Questions and Answers on System Suitability Tests (SST) - Part 1
18.12.2025PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!
18.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations
17.12.2025FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory
17.12.2025FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity