EDQM website search engine deactivated

EDQM 02/03/2020 Strasbourg, France

The EDQM regrets to inform its users that the search engine on its website has been deactivated and is currently unavailable for technical reasons. We are aware of this recurring issue and are working on a long-term solution. We therefore request that our users refrain from contacting the EDQM...

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Nitrosamine contamination: new web page on EDQM response

EDQM 28/01/2020 Strasbourg, France

A new web page providing centralised access to all information related to nitrosamine contamination is now available on the EDQM website. It presents a general overview of the issue and provides details of the actions taken in the different sectors of activity concerned: the European...

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EDQM launches a new HelpDesk

EDQM 21/11/2019 Strasbourg, France

As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer...

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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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First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)

EDQM 03/04/2019 Strasbourg, France

Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major...

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20 years of sampling & testing programme for medicines authorised for the EU

EDQM 27/03/2019 Strasbourg, France

The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s...

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Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

EDQM 14/01/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering assay (in vitro cell-based test) for residual pertussis toxin testing in acellular pertussis vaccines, as of next year. The...

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Major 3Rs achievement for Official Control Authority Batch Release of human vaccines

EDQM 11/12/2018 Strasbourg, France

In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s protocol...

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EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals

EDQM 06/12/2018 Strasbourg, France

The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in...

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New OMCL method for simultaneous determination of NDMA and NDEA in sartans

EDQM 11/10/2018 Strasbourg, France

Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) potentially present in valsartan and other sartan...

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OMCLs release three methods for determination of NDMA in sartans

EDQM 21/09/2018 Strasbourg, France

Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different...

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Update on EDQM’s actions following detection of impurity in valsartan

EDQM 28/08/2018 Strasbourg, France

The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.

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OMCLs discuss Brexit and updates to medicines’ testing methods at annual meeting

EDQM 25/05/2018 Strasbourg, France

The Annual Meeting of the Official Medicines Control Laboratories (OMCLs) took place on 14-18 May in Sarajevo (Bosnia and Herzegovina). It was attended by 230 participants from 38 countries, representing 65 official laboratories and including a representative of the OMCL Network, the Taiwan Food...

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Revised: Human vaccines guidelines with aP components

EDQM 09/04/2018 Strasbourg, France

  The human Official Control Authority Batch Release (OCABR) Network has adopted revisions to 9 human vaccine guidelines for vaccines containing acellular pertussis components. The update removes the requirement for the Official Medicines Control Laboratories (OMCLs) to perform the histamine...

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Revised: “Validation of Computerised Systems” Guideline

EDQM 09/04/2018 Strasbourg, France

Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have...

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