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European Pharmacopoeia / Ph. Eur. Commission | News | 17 April 2018 | Strasbourg, France
The Ph. Eur. Commission decided at its 160th session of March 2018 to reactivate its dedicated GTP Working Party. Experts from both Ph. Eur. and non Ph. Eur. member states are welcome to participate in this work.
Products and Services | News | 17 April 2018 | Strasbourg, France
The 2019 subscriptions are now available for sale on our webstore. Don’t delay, order your subscription now!
European Pharmacopoeia / Ph. Eur. Commission | News | 16 April 2018 | Strasbourg, France
The European Pharmacopoeia Commission achieved an important milestone on quality requirements for Live Biotherapeutic Products (LBPs) for human use with the adoption of quality standards.
European Pharmacopoeia / General text/chapter | News | 13 April 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission launches a public consultation on its proposal to replace the Histamine Sensitisation Test (HIST) for residual pertussis toxin testing.
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 09 April 2018 | Strasbourg, France
OCABR guidelines for vaccines with acellular Pertussis (aP) components have been revised to remove an animal test used for OCABR.
European network of OMCLs / General European OMCLs Network activities | News | 09 April 2018 | Strasbourg, France
GEON quality management document: The guideline “Validation of Computerised Systems” has been revised
Certification of suitability (CEP) / Procedure of certification (general) | News | 09 April 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Ph. Eur. Commission | News | 06 April 2018 | Strasbourg, France
At its 160th session the Ph. Eur. Commission adopted a new version of one of its major general methods, which has undergone extensive revision. The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced in many general texts and more than 1200 individual monographs.
European Pharmacopoeia / Ph. Eur. Commission | News | 05 April 2018 | Strasbourg, France
At its latest Session, the European Pharmacopoeia Commission adopted 19 new monographs, 3 new chapters, 51 revised monographs and 15 revised chapters.
European Pharmacopoeia / Monograph | News | 03 April 2018 | Strasbourg, France
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468).
Products and Services | News | 03 April 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Products and Services | News | 03 April 2018 | Strasbourg, France
4 new Ph. Eur. Reference Standards (RS) were released in March 2018
Pharmaceutical care / Publications | News | 15 March 2018 | Strasbourg, France
The EDQM has issued its Guidelines on ‘Best Practice for the Automated Dose Dispensing (ADD) Process and Care and Safety of Patients’. ADD is an automated process, which allows one or more medicinal products to be dispensed into a container/pouch for a patient to take at a particular date and time.
Products and Services | News | 12 March 2018 | Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in February 2018
Transfusion / Legal Framework | News | 22 February 2018 | Strasbourg, France
The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017.