Skip to main content Skip to search Skip to main navigation
News: Europe

EDQM: New Ph. Eur. Chapter on Data Quality with a Focus on Digital Data

The European Pharmacopoeia (Ph. Eur.) has introduced a new general chapter that provides a framework for managing the quality of data, including digital data, throughout its life cycle. 

It covers aspects such as accuracy, completeness, reproducibility, and bias, as well as the role of experts in automated decision-making. The chapter will come into force with Ph. Eur. Issue 12.3 on 1 July 2026.


Source:

EDQM: Newsroom

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

News: EMA

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

Read more
Question of the Week | GMP-Verlag

Why is it Important to use Consistent Microbiological Air Monitoring Methods in Pharmaceutical Cleanrooms?

Here's the answer:
Read more
Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Robust PDE reports form the basis of risk-based cleaning validation. This article highlights common deficiencies identified during GMP inspections and explains how they can be avoided.

Read more
News: Europe

EDQM: New Working Party on 3D-printed Medicinal Products

The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
Read more
EMA: 14 New Nitrosamines for Appendix 1

EMA: 14 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
Read more
WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
Read more
Previous
Next