European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 11 December 2018 | Strasbourg, France
In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s protocol section (Section 3) have been revised to delete the test.
European network of OMCLs | News | 17 October 2018 | Strasbourg, France
Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active substances. The EDQM contacted those manufacturers of valsartan and other sartans holding CEPs which might...
European network of OMCLs | News | 11 October 2018 | Strasbourg, France
Today the first method for simultaneous determination of NDMA and NDEA in Sartan tablets, developed and validated for Valsartan tablets has been released by the German OMCL in Karlsruhe.
European network of OMCLs | News | 21 September 2018 | Strasbourg, France
Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.
European network of OMCLs | News | 14 September 2018 | Strasbourg, France
The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a...
Certification of suitability (CEP) | News | 28 August 2018 | Strasbourg, France
The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.