EDQM / All activities | News | 08 April 2019 | Strasbourg, France
Due to the Easter weekend, the EDQM will be closed from Friday 19 April and will reopen Tuesday 23 April 2019.
European network of OMCLs / General European OMCLs Network activities | News | 03 April 2019 | Strasbourg, France
Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories...
European network of OMCLs / General European OMCLs Network activities | News | 27 March 2019 | Strasbourg, France
The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant...
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.