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Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations

30/10/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated...

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Pharmacopoeial Discussion Group Achievements

22/10/2018 Strasbourg, France

The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.

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Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines

17/10/2018 Strasbourg, France

Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active...

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EDQM launches public consultation on first pilot monographs for European Paediatric Formulary

16/10/2018 Strasbourg, France

The EDQM has launched a public consultation on the first two pilot monographs and on two general texts for its European Paediatric Formulary. Pharmacists and paediatricians across Europe are called to provide their feedback on the draft monographs on Hydrochlorothiazide oral solution and on...

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Quality of gene therapy products: EDQM listens to stakeholders’ needs

08/10/2018 Strasbourg, France

The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field...

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