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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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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Risk of the presence of mutagenic azido impurities in losartan active substance

EDQM 29/09/2021 Strasbourg, France

In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a...

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Certification of suitability: revised terms of reference and rules of procedure

EDQM 27/09/2021 Strasbourg, France

A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the...

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New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders

EDQM 24/09/2021 Strasbourg, France

From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM...

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Certification monthly report of activities: August 2021

EDQM 14/09/2021 Strasbourg, France

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

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Revised guidance for electronic submissions for CEP applications

EDQM 01/09/2021 Strasbourg, France

As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3

EDQM 15/07/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The table below lists the substances affected by these revisions and for which CEPs have been granted.

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Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders

EDQM 13/07/2021 Strasbourg, France

Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below. The table at the end of this announcement...

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Certification monthly report of activities: June 2021

EDQM 08/07/2021 Strasbourg, France

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

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EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers

EDQM 02/07/2021 Strasbourg, France

Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a...

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The Council of Europe appoints future EDQM Director

EDQM 28/06/2021 Strasbourg, France

The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021. Petra Dörr comes to the EDQM with more than 25 years of...

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Certification monthly report of activities: May 2021

EDQM 08/06/2021 Strasbourg, France

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

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Sign up today! EDQM Virtual Training Programme - Modules on Ph. Eur., RS & CEP Procedure

EDQM 07/06/2021 online

This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia...

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Revision of the document “Implementation of policy on elemental impurities in the Certification Procedure”

EDQM 19/05/2021 Strasbourg, France

The EDQM document “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances...

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Certification monthly report of activities: April 2021

EDQM 06/05/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

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Risk of presence of mutagenic azido impurities in sartan active substances with a tetrazole ring

EDQM 29/04/2021 Strasbourg, France

Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested. The review of the data received,...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.2

EDQM 21/04/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.2. The table below lists the substances affected by these revisions and for which a certificate of suitability to the Ph....

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Certification monthly report of activities: March 2021

EDQM 08/04/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

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Certification monthly report of activities: February 2021

EDQM 12/03/2021 Strasbourg, France

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

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