EDQM publishes New Chapter "Quality of Data" for Comments
Recommendation
22/23 January 2025
Ensuring Control of Chromatographs, Integration and Results
Register now for ECA's GMP Newsletter
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
11.12.2024Another FDA Warning Letter Based on Review of Records
04.12.2024FDA Warning Letter to South African OTC Drug Manufacturer
02.12.2024How to keep Analytical Systems Current and Compliant
27.11.2024FDA Inspections in the EU: Warning Letter to Italian OTC Drug Manufacturer
21.11.2024New GMP Journal Article on Analytical Instrument Qualification and System Validation
21.11.2024FDA Warns Chinese OTC Drug Manufacturer Following Review of Records