Journal of Pharmaceutical and Biomedical Analysis publishes results of the OMCL fingerprint study on omeprazole API samples

EDQM 02/12/2021 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on omeprazole, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021). An API fingerprint is a...

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Change in EDQM timelines for CEP applications

EDQM 26/11/2021 Strasbourg, France

On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in...

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SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)

EDQM 15/11/2021 Strasbourg, France

After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...

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EDQM Laboratory’s ISO 17025:2017 accreditation renewed

EDQM 15/11/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results...

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Shipments of orders in December: check EDQM order reception deadlines

EDQM 09/11/2021 Strasbourg, France

To check whether orders for publications or reference standards can be shipped in 2021, users are invited to consult the EDQM order reception deadlines for December. The dates by type of item are given in the following document: Order & shipment deadlines – December 2021. See also: Ph. Eur....

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PDG signs-off on milestone harmonised general chapter on chromatography

EDQM 08/11/2021 Strasbourg, France

The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for...

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Joint presentation of EDQM and DH-BIO about Council of Europe principles of voluntary non remunerated blood donation / prohibition of financial gain with respect to donation at Members of the European Parliament hosted event

EDQM 05/11/2021 Strasbourg, France

Human plasma is the critical component of numerous therapeutic products used in the treatment of life-threatening diseases, including bleeding or immune system disorders and other severe pathologies. In recent years, the global use of and demand for plasma for fractionation have grown and it is a...

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5 new Ph. Eur. reference standards and 19 replacement batches released in October 2021

EDQM 04/11/2021 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4

EDQM 20/10/2021 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.4. The table below lists the substances...

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Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders

EDQM 19/10/2021 Strasbourg, France

Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the...

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PDG prepares pilot for global expansion of membership

EDQM 18/10/2021 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world...

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European Pharmacopoeia device version to be discontinued

EDQM 15/10/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions. The EDQM was the...

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Revised osmolality chapter for public comment in Pharmeuropa

EDQM 14/10/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021). The revision work focused on the osmolality reference solutions using...

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Registrations open! Brand new Quality Risk Management training for blood establishments

EDQM 14/10/2021 Strasbourg, France

The supply of blood components involves a series of complex processes composed of numerous steps, each carrying intrinsic and extrinsic risks. Blood establishments must continuously adapt to new regulatory and technical requirements in quality management as part of their risk avoidance strategy....

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Application date closed - Recruitment in progress : Scientific Assistant – Hazard Classification

EDQM 13/10/2021 Strasbourg, France

Do you have experience in chemical hazard classification and/or Safety Data Sheet (SDS) requirements? Are you detail-oriented and able to work under pressure and meet deadlines? 

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European Day for Organ Donation and Transplantation, 9 October 2021: Join us online to celebrate! #JustSayYesEODD

EDQM 09/10/2021 Strasbourg, France

This year, celebrations for the European Day for Organ Donation and Transplantation (EODD) will take place online on Saturday, 9 October. EODD is an opportunity to discuss organ, tissue and cell donation and transplantation and reflect upon their importance, as well as to thank donors, their...

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4 new Ph. Eur. reference standards and 21 replacement batches released in September 2021

EDQM 08/10/2021 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European...

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Certification monthly report of activities: September 2021

EDQM 08/10/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. September 2021 Certification Monthly Report For more information, access the Certification Database.

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New in European Paediatric Formulary: Phosphate oral solution monograph

EDQM 07/10/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Phosphate 60 mg/mL Oral Solution, to the European Paediatric Formulary. Elaborated by a dedicated European Pharmacopoeia (Ph. Eur.) working party, the monograph was initially published in Issue 3...

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Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa

EDQM 06/10/2021 Strasbourg, France

A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021. This draft monograph is the outcome of a...

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