In this post you find European Pharmacopoeia 11th Edition pdf free download of every single monograph and separate General Chapter of all in zip file size of 500mb.
Since it guarantees that medications are consistently of high quality and safety, the EP is a crucial tool for the pharmaceutical industry. The EP monographs detail the substance's chemical and physical characteristics as well as tests for impurities and other quality characteristics. Manufacturers use this information to create and test their products, and regulators use it to check for adherence to the EP standards.
The primary source of official quality standards for medications and their ingredients in Europe is the European Pharmacopoeia (Ph. Eur. Ph. Eur. standards support the pharmaceutical industry and healthcare systems by providing a scientific foundation for the quality control of a product throughout its life cycle.
These standards are required by law, as stated in the Council of Europe Convention on the Development of a European Pharmacopoeia, as well as in national and European Union pharmaceutical regulations. In all states that have ratified the convention, they all become necessary on the same day.
European Pharmacopoeia 11th Edition
Why do you need the European Pharmacopoeia?
The European Pharmacopoeia Commission continuously revises general texts and monographs, re-evaluates the relevance of animal tests mentioned in European Pharmacopoeia texts and, if deemed appropriate, includes alternative methods. The general monograph on Vaccines for veterinary use (0062) was revised to delete the TABST (target animal batch safety test), except in ‘particular circumstances’ to cover the need to perform, on an ad hoc basis, further testing and safety tests in particular.
In the interest of the 3Rs, the European Pharmacopoeia Commission also adopted the deletion of the TABST from the European Pharmacopoeia for all veterinary vaccines. Currently, at the European Pharmacopoeia level, animals are no longer used in the testing of medicinal products derived from human blood and plasma.
In many cases, in vivo testing has been replaced by in vitro methods for human and veterinary vaccines. For the remaining in vivo assays, different strategies are being used to promote reduction and refinement of animal use, e.g. serology assays or single dilution assays for diphtheria, tetanus, acellular pertussis and rabies (veterinary/human) vaccines.
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
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