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Certification of suitability (CEP) / Procedure of certification (general) | News | 12 June 2019 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
EDQM / All activities | News | 06 June 2019 | Strasbourg, France
The latest EDQM Annual Report provides an overview of its accomplishments. In 2018 much was accomplished in the field of setting quality standards for the manufacture and control of medicines in Europe and beyond.
Certification of suitability (CEP) / Good manufacturing practice (GMP) | News | 09 May 2019 | Strasbourg, France
A review of data from API inspections conducted by the EDQM between 2006 and 2018 is now available.
European Pharmacopoeia / General text/chapter | News | 10 April 2019 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.2 before 30 June 2019.
Certification of suitability (CEP) / CEP suspension | News | 04 February 2019 | Strasbourg, France
Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended CEP R1-CEP 2009-247-Rev 02/losartan potassium, form I, held by HETERO LABS, Limited, due to the detection of low levels of N-nitroso-N-methylamino butyric acid (NMBA) and N-nitroso-...
Products and Services | News | 24 January 2019 | Strasbourg, France
The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 January 2019 | Strasbourg, France
Supplement 9.8 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP suspension | News | 18 January 2019 | Strasbourg, France
Following new information received recently by EDQM about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions will have been implemented by the relevant company: due to the detection of low levels of N-nitrosodiethylamine (NDEA), suspension of the CEP R1-CEP 2010...