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     * EDQM response to nitrosamine contamination
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     * Events
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     * Elaborations & Revisions
     * Where to find: the Knowledge database
     * The Ph. Eur. work programme
   * Pharmacopoeial Harmonisation
     * International harmonisation
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     * Harmonisation status for General Texts (PDG)
   * The European Pharmacopoeia (Ph. Eur.)
     * Background & Mission
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Pharmeuropa 33.4 just released
European Pharmacopoeia / Public enquiry News 05 October 2021 Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone
technical revisions are published in Pharmeuropa for public consultation. The
deadline for comments on Pharmeuropa 33.4 is 31 December 2021.
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Vacancy: Scientific Programme Manager – Blood transfusion activities
Transfusion / General News 05 October 2021 Strasbourg, France
Main responsibilities of the job: As a Scientific Programme Manager, you will
help draft guides and develop guidelines and/or co-ordinate and promote
co-operation activities to improve quality, safety and ethical standards for the
collection, storage and distribution of blood and...
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European Pharmacopoeia Supplement 10.7 now available
European Pharmacopoeia / Monograph News 04 October 2021 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will
be applicable in 39 European countries as of 1 April 2022.
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MORE NEWS

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Certification of suitability: revised terms of reference and rules of...
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...
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New EDQM IT tool for the management of CEP activities – Impact for...
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...
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OMCL Annual Meeting 2021: European Quality Control Programmes and...
The 26th Annual Meeting of the European Network of Official Medicines Control
Laboratories (OMCLs) took place from 6 to 10 September 2021 and was held
virtually due to the ongoing pandemic situation. The meeting, organised by
the...
See all news


AGENDA

20 October 2021 to 25 November 2021
online
NEW: Training course on Quality Management for Tissue Est...

See all events

See Reference standards Catalogue
Ph. Eur. 10th Edition presentation
Reference Standards & publication store
Free Publications and Databases
Certification of Suitability (CEP) News
Have a question? FAQ & HelpDesk
https://www.edqm.eu/en/edqms-response-nitrosamine-contamination

Nitrosamine contamination
In brief
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Since N-nitrosamines, possible carcinogens for humans, were detected in 2018 in
a number of active substances, the EDQM has been working with regulatory
authorities to ensure that no medicinal products containing nitrosamine
contaminants reach the end user. This has involved, among others, reviewing
Certificates of suitability (used in marketing authorisation applications),
revising European Pharmacopoeia monographs for the active substances concerned
and establishing new reference standards to support the implementation of the
new Ph. Eur. general chapter on the analysis of N-nitrosamines. The EDQM OMCL
Network has also co-ordinated the development of testing procedures that ensure
adequate control of impurities and a risk-based sampling and testing programme.

https://www.edqm.eu/en/news/all

The Vision of the EDQM
In brief
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 * A Directorate of the Council of Europe created in 1964.
 * A leading organisation that protects public health by enabling the
   development, supporting the implementation and monitoring the application of
   quality standards for safe medicines and their safe use.
 * Also develops guidance and standards in the areas of blood transfusion, organ
   transplantation and consumer health issues.

https://www.edqm.eu/en/news/european-pharmacopoeia

The European Pharmacopoeia
In brief
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 * Main objective is to provide common quality standards to control the quality
   of medicines and of substances used in the manufacture of medicines (human
   and veterinary use).
 * Legally binding in European member states.
 * 39 signatory parties (including the EU) and 30 observers (including WHO and
   TFDA) as of March 2018.

https://www.edqm.eu/en/news/omcl-network

Official Medicines Control Laboratories (OMCL)
In brief
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 * A network of independent public laboratories appointed by the national
   authorities.

 * Around 70 laboratories provide human and technical resources to implement
   testing programmes.

 * 36 European countries and 5 countries outside Europe participate in the
   various activities and programmes.

https://www.edqm.eu/en/news/certification-of-suitability

The Certification of Suitability
In brief
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 * Established in 1994.
 * Over 4,900 certificates covering more than 1,100 substances have been granted
   in more than 60 countries.
 * Assessment is jointly performed by a network of around 100 assessors from the
   national competent authorities and EDQM assessors.
 * Organises an inspection programme involving a network of around 30 inspectors
   from 20 different national competent authorities and the EDQM.

 

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https://www.edqm.eu/en/edqms-contributions-protection-public-health-covid-19-pan…

COVID-19 pandemic
Focus
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The EDQM’s core activities include the provision of documentary and physical
(reference) standards to ensure the quality of medicines and their ingredients.
Availability of and access for patients to quality medicines is more important
than ever in the context of the current COVID-19 pandemic. This is why the EDQM
is working hard to ensure the continuous supply of our goods and services and is
engaging with all stakeholders, including national, European and international
authorities, to help protect public health.

 * The EDQM’s contributions to the protection of public health in the COVID-19
   pandemic: latest information
 * EDQM business continuity plan to safeguard core activities
 * EDQM initiatives in the context of COVID-19 vaccines and therapies

 

 


LATEST PRODUCTS AND SERVICES

05 August 2021
6 new reference standards and 16 replacement batches released in July...
05 July 2021
Pharmeuropa 33.3 just released
See all Products and Services news


HOW TO ORDER

Via our web store at store.edqm.eu in order to benefit from free handling
charges (on publications only). Alternatively, you can send your order to the
EDQM Sales section by:

 * post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg,
   France
 * e-mail: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.


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