What is the current version of Ph Eur?
Eur. 10th Edition – Now available! The 10th Edition of the European Pharmacopoeia, which is applicable in 38 European countries from 1 January 2020 and is used in over 100 countries worldwide, is now available!
What does Ph Eur stand for?
European Pharmacopoeia
Why you need the European Pharmacopoeia The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control during the entire life cycle of a product.
Is Ph Eur the same as EP?
Answer: The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament).
How do I access European Pharmacopoeia?
Register for access
- On the Pharmeuropa homepage, click on “Register” on the right of the menu bar.
- Enter the e-mail address that will serve as your login, fill in the captcha, then click on “Next”.
- Complete the registration and follow the instructions in the e-mail confirmation.
How do I access Pharmacopoeia?
How to register for access to Pharmeuropa Online
- On the Pharmeuropa homepage, click on “Register” on the right of the menu bar.
- Enter the e-mail address that will serve as your login, fill in the captcha, then click on “Next”.
- Complete the registration and follow the instructions in the e-mail confirmation.
Who is International Pharmacopoeia?
Int.) is a pharmacopoeia issued by the World Health Organization as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, together with supporting general methods of analysis, for global use.
What is EP in pharmacy?
European Pharmacopoeia (EP): The official standards for medicines in Europe, including bulk drug substances, chemical and biological analytical methods, and reagents. compendia of the United States of America for excipients, drug substances, and drug products.
What is Edqm audit?
The EDQM inspection programme is an integral part of the Certification procedure and is elaborated in the context of the mandate given to the EDQM by the European Commission in the application of Directives 2001/83/EC and 2001/82/EC as amended. About 40 inspections are performed every year, including re-inspections.
What is JP in medicine?
The most referenced pharmacopeias are the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP). pharmaceutical substances in the United Kingdom. description and quality of excipients, drug substances, and drug products.
What is EU Pharmacopeia?
A compendium of texts on the qualitative and quantitative composition of medicines, and on the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis.
WHO publishes the European Pharmacopoeia?
the Council of Europe
A new edition of the European Pharmacopoeia is published every three years: in both English and French, by the Council of Europe. It is made available in print and electronic (online and downloadable) versions; the online version is also accessible from smartphones and tablet computers.
Is British Pharmacopoeia free?
The European Pharmacopoeia and the British Pharmacopoeia have worked together to make supportive pharmacopoeial texts (monographs, general chapters, appendices and supplementary chapters) available for a limited period of time at no cost to users.
Who is the chair of the European Pharmacopoeia Commission?
The European Pharmacopoeia Commission. The current Chair of the Commission is Dr Tobias Gosdschan, who was elected in March 2016. Dr Gosdschan’s term for Chair is three years, and runs in parallel with other members of the Commission’s Presidium.
What makes the European Pharmacopoeia mandatory in Europe?
Several legal texts make the European Pharmacopoeia mandatory in Europe. The Convention on the Elaboration of a European Pharmacopoeia (ETS No. 50) which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia.
When is European Pharmacopoeia General Chapter 2.1.7 balances for analytical purposes?
The new General Chapter 2.1.7 “Balances for Analytical Purposes” will be published in July 2021 as part of the European Pharmacopoeia (Ph. Eur.) Supplement 10.6. What is new? General Chapter 2.1.7: States that the calibration results must be documented in a calibration certificate and must include measurement uncertainty.