EDQM: New General Chapter 'Quality of Data' available
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The new general chapter '5.38. QUALITY OF DATA' was made available in January with the release of version 12.3 of the European Pharmacopoeia (Ph. Eur. 12.3).
This new chapter was open for public comment in 2024 and is scheduled to come into force in July 2026. The content of the new general chapter completes the data of the following chapters:
- '5.21. Chemometric methods applied to analytical data'
- '5.28. Multivariate statistical process control'
- '5.33. Design of Experiments'
- '5.24. Chemical Imaging'
- '5.25. Process analytical technology'
As already reported in a past news, the new general chapter refers to digital data that is generated, collected or used by quality control laboratories. It highlights its increasing importance for evaluating the quality compliance of medicinal products. A particular focus is placed on the life cycle management of digital data.
The complete chapter '5.38. QUALITY OF DATA' can be accessed in Ph. Eur. 12.3. A summary is available in the news section of the EDQM website.
