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Certification of suitability (CEP) / CEP revision | News | 19 May 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 for veterinary use.
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 May 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 29 April 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.
News | 21 April 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. Eur. monographs (CEP) has been granted.
News | 08 April 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.