EN FR

Certification monthly report of activities: End of May 2024

EDQM 10/06/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation

EDQM 17/05/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation in the consultation space. The consultation deadline for this document...

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EN FR

Certification monthly report of activities: End of April 2024

EDQM 06/05/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

How to identify the manufacturing sites linked to CEP application (revised document)?

EDQM 08/04/2024 Strasbourg, France

Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...

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EN FR

CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2

EDQM 08/04/2024 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 36.2. The table below lists the substances...

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EN FR

Certification monthly report of activities: End of March 2024

EDQM 08/04/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools

EDQM 04/04/2024 Strasbourg, France

The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1 May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the use...

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EN FR

How CEP holders can avoid the rejection of notifications

EDQM 28/03/2024 Strasbourg, France

In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...

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EN FR

The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!

EDQM 25/01/2024 Strasbourg, France

A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...

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EN FR

Certification monthly report of activities: End of February 2024

EDQM 05/03/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Save the date: webinar on CEP 2.0

EDQM 26/02/2024 Strasbourg, France

The EDQM invites CEP holders and users to participate in a public webinar on the 9th April 2024 to share their experiences on the use of CEP 2.0. More info at: https://www.edqm.eu/en/cep-2-0-fresh-feedback-from-stakeholders

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EN FR

Certification monthly report of activities: End of January 2024

EDQM 09/02/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!

EDQM 08/02/2024 Strasbourg, France

This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. The content of this document is intended to help applicants to build their application in conjunction with the EDQM...

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EN FR

EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...

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EN FR

CEP holders invited to comment on draft monographs published in Pharmeuropa 36.1

EDQM 22/01/2024 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 36.1. The table below lists the substances...

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EN FR

EDQM clarifies its policy for confidentiality and declassification of CEP documents

EDQM 19/01/2024 Strasbourg, France

EDQM has elaborated a document describing the principles for the declassification of documents pertaining to the CEP procedure while ensuring when necessary, the confidentiality of information.

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EN FR

Certification monthly report of activities: End of December 2023

EDQM 09/01/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2023 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Implementation of the European Pharmacopoeia Supplement 11.5 – Notification for CEP holders

EDQM 19/12/2023 Strasbourg, France

Supplement 11.5 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 July 2024, and to follow the...

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EN FR

The CEP 2.0 guideline on requirements for the content of the dossier has been updated

EDQM 13/12/2023 Strasbourg, France

The guideline on requirements for the content of the CEP dossier according to the CEP 2.0 has been revised to include updated requirements and clarifications related to sections 3.2.S.4.1 & 3.2.S.4.2. and an updated Annex 1.

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EN FR

Information for CEP applicants - EDQM-DCEP non-working days in 2024

EDQM 11/12/2023 Strasbourg, France

In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...

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