Table of Contents
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.
What is pharmacopoeia monograph?
A pharmacopeial monograph provides detailed parameters that are used to determine whether a medicine meets key quality attributes and can be marketed legally in any given country.
What is certification of suitability to the monographs of the European Pharmacopoeia?
The procedure for “Certification of Suitability to the monographs of the European Pharmacopoeia” was established in 1994 and was in the beginning restricted to controlling the chemical purity of pharmaceutical substances.
How many monographs are there in British Pharmacopoeia?
3,000 monographs
The current edition of the British Pharmacopoeia comprises six volumes, which contain nearly 3,000 monographs for drug substances, excipients, and formulated preparation, together with supporting general notices, appendices (test methods, reagents etc.), and reference spectra, used in the practice of medicine, all …
What is the definition of monographs?
Definition of monograph (Entry 1 of 2) : a learned treatise on a small area of learning his concise monograph on The Authorship of Shakespeare’s Plays— Brian Vickers also : a written account of a single thing wrote a monograph on the art of origami. monograph. verb. monographed; monographing; monographs.
What is official monograph?
Key components. A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include: Identity – Tests to identify that a particular substance is the medicine that it claims to be.
What is CEP for API?
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 is another word for monograph?
In this page you can discover 14 synonyms, antonyms, idiomatic expressions, and related words for monograph, like: dissertation, essay, tract, discourse, thesis, treatise, monographic, bibliography, , and pamphlet.
What is monograph in Indian Pharmacopoeia?
IP is a compilation of official standards for drugs manufactured and/or marketed in India. A monograph states the quality or test parameters, the acceptance criteria and details of the tests that are to be performed to determine compliance with the criteria.
Why are monographs important?
Monographs are used as reference sources to build bibliographies and discover relevant references. They are also important as syntheses of literature in the field, valued for their comprehensive, in-depth, and definitive perspectives.
What is dossier in pharma?
Abstract : Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data.
Are BP and EP monographs the same?
The BP contains thousands of monographs and one of our areas of expertise is in finished products, while the EP predominantly focuses on starting materials and active pharmaceutical ingredients.