The Ph. Eur. revises its general chapter on UV-Vis absorption spectrophotometry

EDQM 15/07/2019 Strasbourg, France

At its 162nd session in November 2018, the Ph. Eur. Commission adopted a new version of one of its major general methods. Ultraviolet and visible absorption spectrophotometry (2.2.25) has undergone extensive revision and is published in the 10th Edition (implementation date 1 January 2020). This...

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Dosage Form Monographs for Public Consultation

EDQM 15/07/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving intravesical...

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Pharmeuropa 31.3 just released

EDQM 12/07/2019 Strasbourg, France

All new texts and texts having undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts. It should be noted that: Although draft monographs must not be regarded as official standards, they will, once...

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EDQM conference addresses key issues and work priorities for tomorrow’s medicines

EDQM 09/07/2019 Strasbourg, France

The international conference “EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines” took place on 19 to 20 June 2019 in Strasbourg to mark the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th Anniversary of the European OMCL Network...

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Monograph on Rosuvastatin tablets (3008) to be published in Ph. Eur. 10.1

EDQM 08/07/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new monograph on Rosuvastatin tablets (3008) at its 163rd session (March 2019). The monograph will be published in the 1st supplement to the 10th Edition (available in October 2019) and will become effective on 1 April 2020....

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164th Session of the European Pharmacopeia Commission and election of Vice-chairs

EDQM 08/07/2019 Strasbourg, France

Following the election of its new Chair, Prof. Torbjörn Arvidsson, at its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Salvador Cañigueral as its first Vice-chair for a term of three years (2019-2022). Mr Goran Benkovic was elected as second Vice-chair. The...

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15 new reference standards and 22 replacement batches released in June 2019

EDQM 04/07/2019 Strasbourg, France

The EDQM announces the availability of: 15 New Ph. Eur. reference standards Catalogue code Name Unit Quantity Y0002128 Carmustine 60 mg Y0002122 Prasugrel hydrochloride 70 mg Y0002119 Prasugrel for system suitability 10 mg Y0002116 Propyl gallate for ID and assay 80 mg Y0002114 Tapentadol...

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Ph. Eur. Commission consults stakeholders on the general chapter on Multivariate Statistical Process Control (MSPC) (5.28)

EDQM 04/07/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on the new chapter 5.28 on Multivariate Statistical Process Control. The Ph. Eur. is the first pharmacopoeia to elaborate such a chapter. Multivariate statistical process control (MSPC) can be defined as the...

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Update on the EDQM review of CEP applications for sartans and next steps (June 2019)

EDQM 18/06/2019 Strasbourg, France

The EDQM has now finalised the review and update of the vast majority of CEP dossiers for sartans containing a tetrazole ring structure. The CEP dossiers have been assessed following a risk- and science-based approach. When sufficient data was given to demonstrate that there were no risks of...

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General chapter 5.8 Pharmacopoeial harmonisation: new concept for the Ph. Eur. 10th Edition

EDQM 13/06/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of the general chapter on Pharmacopoeial harmonisation (5.8) which will be published in the upcoming 10th Edition (implementation date 1 January 2020). The concept of the chapter has changed significantly. In the future,...

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World Blood Donor Day June 14, 2019: “By donating blood, you can save lives!”

EDQM 13/06/2019 Strasbourg, France

EDQM supports World Blood Donor Day on 14 June 2019. We invite all our website visitors and social media followers to consider blood donation and to mobilise their families, friends and colleagues to do the same. When it comes to blood donation, every link in the chain matters! Discover the...

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OMCL Network discusses strategy and reviews past year’s activity at annual meeting

EDQM 04/06/2019 Strasbourg, France

  The 24th annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs), jointly organised by the EDQM and the Medicines and Healthcare products Regulatory Agency (MHRA, UK), took place on 13-17 May in London. It was attended by 260 participants from 40 countries,...

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Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

EDQM 17/05/2019 Strasbourg, France

In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin)...

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2 new Ph. Eur. Reference Standards (RS) and 21 replacement batches released in April 2019

EDQM 15/05/2019 Strasbourg, France

The EDQM announces the availability of: 2 New Ph. Eur. Reference Standards: Y0002073 Betacarotene for system suitability, Y0002096 Ginsenoside Rg1 21 Replacement batches for Ph. Eur. Reference Standards: B0900000 Benzylpenicillin sodium, B1145000 Bromhexine hydrochloride, D0710000 Dexamethasone...

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EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018 (PA/PH/CEP(18) 56 April 2019)

EDQM 09/05/2019 Strasbourg, France

A review of data from API inspections conducted by the EDQM between 2006 and 2018 is now available. This document summarises the trends of deficiencies observed in EDQM inspections with reference to EU GMP and to the corresponding CEP dossiers. Overview 2006 to 2018 PA/PH/CEP (18) 56

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EDQM reports issues of non-compliance with tooth whitening products

EDQM 02/05/2019 Strasbourg, France

The quality of tooth whiteners and whitening strips was assessed in a Market Surveillance Study carried out in 12 European countries and completed in 2018 by the network of Official Cosmetics Control Laboratories (OCCLs), coordinated by the EDQM. The findings, based on the testing of 261 samples...

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Pharmacopoeial discussion group videoconference meeting - March 2019

EDQM 23/04/2019 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on Wednesday 13 March 2019. The PDG, which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) with WHO (International Pharmacopoeia) as Observer, to...

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4 new Ph. Eur. Reference Standards (RS) and 21 replacement batches released in March 2019

EDQM 09/04/2019 Strasbourg, France

The EDQM announces the availability of: 4 New Ph. Eur. Reference Standards: Y0002046 Griseofulvin for LC assay and identification, Y0002061 Everolimus for system suitability, Y0002090 Regorafenib monohydrate, Y0002097 Nilotinib hydrochloride monohydrate. 21 Replacement batches for Ph. Eur....

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EDQM releases proceedings from its training sessions on Quality Management Systems and Statistical Process Control for Blood Establishments

EDQM 08/04/2019 Strasbourg, France

The EDQM has made available on its website the proceedings of two of its recent training sessions on Quality Management Systems (QMS) and Statistical Process Control (SPC) for Blood Establishments. These proceedings provide Blood Establishments in Europe with the latest knowledge on Quality...

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