How do you cite European Pharmacopoeia?
The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament). A good example of a reference would be: Ph.
How do I access European Pharmacopoeia online?
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 you read a CEP certificate?
This document should be read in conjunction with other applicable Certification Policy Documents and Guidelines. A CEP covering chemical purity and microbiological quality certifies, based on the specific data supplied by the manufacturer, that the quality of a substance can be suitably controlled by the Ph.
What is EP reference standard?
Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis, for example, for identification, purity tests or assays according to the corresponding monograph of general chapter of the European Pharmacopoeia.
What is European Pharmacopoeia monograph?
It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
Who is the author of the European Pharmacopoeia?
Council of Europe
Details
| Genre/Form: | Directories |
|---|---|
| Document Type: | Book |
| All Authors / Contributors: | Council of Europe.; European Pharmacopoeia Commission. |
| ISBN: | 9287160546 9789287160546 9789287160577 9287160570 9789287160591 9287160597 |
| OCLC Number: | 170932841 |
What is a EP monograph?
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.
How often is EP updated?
A new edition of the European Pharmacopoeia is published every three years: in both English and French, by the Council of Europe.
What are CEP filings?
An API’s (active pharmaceutical ingredient) Certificate of Suitability (CEP) proves that its quality complies with the quality described in the relevant monograph of the European Pharmacopoeia; it therefore creates a direct link to the Ph. Eur.
What does EDQM stand for?
European Directorate for the Quality of Medicines
EDQM – European Directorate for the Quality of Medicines.
What is the current version of European Pharmacopoeia?
The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph.
What is the latest edition of European Pharmacopoeia?
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 is 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. These standards are legally binding – as laid down in the Council of Europe Convention on the Elaboration
What is the catalogue of reference standards?
The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here.
What is the European Pharmacopoeia working party doing?
A number of important European Pharmacopoeia activities have been initiated over the last few years, such as the establishment of a PAT (Process Analytical Technology) Working Party based on a request from the EMA. PAT tools make it possible to use additional information collected throughout the production process, e.g. use of NIR
How many P4 monographs have been adopted by the European Commission?
59 P4 monographs for chemical substances have been adopted by the European Pharmacopoeia Commission. Under the P4 procedure for chemical substances, a pilot project on bilateral prospective harmonisation of active substance monographs with the USP was initiated and so far has resulted in the adoption of 4 harmonised monographs.