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Project Officer – Buildings
Are you an experienced Building Project Officer? Do you have the potential to oversee all aspects of building projects within a highly scientific environment, from inception through to handover, ensuring they are completed on time, within budget and to the highest standards?
New monographs on an anti-interleukin monoclonal antibody released for public consultation
The European Pharmacopoeia (Ph. Eur.) has published two new draft monographs, Ustekinumab concentrated solution (3165) and Ustekinumab injection (3188), for public comment in this quarter’s issue of Pharmeuropa (36.3). Following the adoption and publication of the monographs for Etanercept...
Ph. Eur. seeks feedback on the use of plastic additive 18
Plastic additive 18 (P-EPQ, for more details see appendix ) is a phenolic antioxidant that may be used as a stabiliser in the processing of plastic materials. It consists of seven components, all of which contribute to the efficiency of the additive, but is a product-by-process (reaction product)...
Publication of outcome of study for Human Immunoglobulin (molecular size) BRP replacement batches
The outcome of the recently completed Biological Standardisation Programme study for the establishment of Human immunoglobulin (molecular size) Biological Reference Preparation (BRP) replacement batches 4, 5 and 6, has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
Call for experts – Join the Bovine Serum Working Party!
Bovine serum is widely used in the manufacture of human and veterinary medicinal products, for example as a supplement in cell culture media for the production of vaccines (both human and veterinary) and advanced therapy medicinal products (ATMPs). The European Pharmacopoeia (Ph. Eur.) monograph...
GMP Inspector
Do you have the right mix of excellent scientific and analytical skills, together with the ability to interpret and assess complex regulatory and Good Manufacturing Practices (GMP) requirements?
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
Shortage of amoxicillin paediatric products: expert opinion of the European Drug Shortages Formulary Working Party
Amoxicillin is an aminopenicillin used to treat a number of infections. In recent years (particularly during the winter months), several member states have reported major difficulties in procuring amoxicillin-containing products, with paediatric forms of the antibiotic especially affected. In...
CEP planning and process Manager
Do you have a scientific background combined with excellent communication and project management skills?
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.3
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.3. The table below lists the substances...
Certification monthly report of activities: End of June 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2024 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
Pyrogen detection is essential for ensuring the safety of parenteral medicines. For decades, the rabbit pyrogen test (RPT) has been the traditional method. The RPT involves measuring the rise in body temperature in rabbits following intravenous injection of the substance to be examined. Despite...
Three revised texts related to pharmaceutical waters published in Pharmeuropa 36.3
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the following revised texts, published in this quarter’s issue of Pharmeuropa (36.3) for comment: Water for injections (0169) Purified water (0008) Total organic carbon in water for pharmaceutical use (2.2.44) The main focus...
Improved CombiStats online application now available
The CombiStats online application is available as of 4 July 2024, with an improved interface, a new licensing system and a dedicated user workspace. Users are invited to start using the online application, by creating an account and following the registration steps. The contact person who placed...
Council of Europe adopts recommendation on reporting of disappearances of medicines
In the past decade, Europe has seen a number of major pan-European cases where medicines have disappeared from the legal supply chain, and then been manipulated or tampered with before being reintroduced into it. This clearly presents a risk for public health. Follow-up enquiries and discussions...
Pharmeuropa 36.3 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.3 is 30 September 2024. Users and interested parties are welcome to comment on these drafts. It...
Outcome of the 179th session of the European Pharmacopoeia Commission, June 2024
The European Pharmacopoeia Commission (EPC) held its 179th session on 18 and 19 June 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the Ph. Eur. Work Programme...
8 new Ph. Eur. reference standard and 18 replacement batches released in June 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
Implementation of the European Pharmacopoeia Supplement 11.6 – Notification for CEP holders
Supplement 11.6 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2025, and to follow the...
European Pharmacopoeia Supplement 11.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.6 is now available and will be applicable in 39 European countries as of 1 January 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic...
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