Certification of suitability (CEP) / Procedure of certification (general) | News | 14 December 2018 | Strasbourg, France
Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised and are available.
Certification of suitability (CEP) / Chemical purity | News | 14 December 2018 | Strasbourg, France
The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019.
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 Pharmacopoeia / Animal testing | News | 06 December 2018 | Strasbourg, France
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents.
European Pharmacopoeia / Ph. Eur. Commission | News | 30 November 2018 | Strasbourg, France
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts and 128 revised texts. All of the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 January 2020 and will be published in 10th Edition of...
European Pharmacopoeia / General text/chapter | News | 28 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
Certification of suitability (CEP) / Procedure of certification (general) | News | 20 November 2018 | Strasbourg, France
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory...
Certification of suitability (CEP) / CEP suspension | News | 19 November 2018 | Strasbourg, France
Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of suitability (CEP) R1-CEP 2009-396-Rev 03/Valsartan held by this company, until appropriate corrective actions are taken.
Reference Standard / General | News | 16 November 2018 | Strasbourg, France
The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical competence of the EDQM laboratory to characterise the official reference standards of the European Pharmacopoeia (...
Transplantation / Legal Framework | News | 08 November 2018 | Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs was ratified by Portugal on 8 November 2018 and will commence having legal effect in the country as of 1 March 2019. The Convention identifies various activities constituting human organ trafficking which ratifying member states must consider as criminal offences.
European Pharmacopoeia / Public enquiry | News | 06 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)
Transplantation / Organ | News | 06 November 2018 | Strasbourg, France
The Organ Guide now in its 7th Edition supports professionals on a practical level to improve the rate of successful and safe organ transplantation. The Organ Guide collates updated information to provide professionals with the most recent advances in the field, as well as technical guidance to ensure the safety and quality of human organs intended for transplantation.
European Pharmacopoeia / Public enquiry | News | 30 October 2018 | Strasbourg, France
Your input is essential to shape future European Pharmacopoeia (Ph. Eur.) monographs and helps keep texts relevant and fit for purpose. The issue 30.4 of Pharmeuropa is complete and ready for comments: manufacturers and users have until 31 December 2018 to provide their feedback on draft Ph. Eur. texts and to verify their products’ compliance with the new or revised drafts monographs.
European Pharmacopoeia / General text/chapter | News | 30 October 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators. Pyrogens are substances...
Products and Services | News | 24 October 2018 | Strasbourg, France
Recently released: 2 new Ph. Eur. Reference standards Zoledronic acid monohydrate and Infliximab BRP, as well as 16 replacement batches