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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
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.
Products and Services | News | 03 April 2018 | Strasbourg, France
4 new Ph. Eur. Reference Standards (RS) were released in March 2018
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.
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).
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.
Reference Standard / Chemical reference standard (CRS) | News | 16 February 2018 | Strasbourg, France
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
Reference Standard / Chemical reference standard (CRS) | News | 01 February 2018 | Strasbourg, France
Four new elemental impurity chemical reference standards (CRS) are available in the European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS.
Transplantation / Organ trafficking | News | 31 January 2018 | Strasbourg, France
Armenia has signed the Council of Europe Convention against Trafficking in Human Organs on 24 January 2018. The Convention, which is now signed by 21 countries and ratified by 5, identifies various activities constituting human organ trafficking as criminal offences and will come into force on 1 March 2018.
European Pharmacopoeia / General text/chapter | News | 18 January 2018 | Strasbourg, France
Revision of the Ph. Eur. general chapters on plasticised PVC materials, following the 159th Commission session (November 2017) of the Ph. Eur. Commission.
Products and Services | News | 02 January 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.