Tag: EDQM

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Revised EDQM Guideline on how to read a CEP

EDQM Publishes Revised Guideline on How to Read a CEP

Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better...
Ph.Eur. Proposes rFC Endotoxin Test Integration and Pyrogen Testing Updates

Ph. Eur. Proposes rFC Endotoxin Test Integration and Pyrogen Testing Updates

Ph. Eur. adds rFC to BET (2.6.14) and updates pyrogen testing (5.1.13) to support sustainable, animal-free methods in line with...
Draft EDQM General Chapter 5.38 Quality of Data

Draft EDQM General Chapter 5.38: Quality of Data

EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement....
EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open...
EDQM Presents 10 Deficiencies in New CEP Applications for Chemical Purity

EDQM Presents 10 Common Deficiencies in New CEP Applications for Chemical Purity

EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications...

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