What is pharmacopoeia monograph?
Herbal monographs in national pharmacopoeias and other authoritative documents play an important role in the authentication of herbal materials. In this context, a monograph is a document that defines a botanical drug and provides information that allows for its proper identification.
What is EDQM in pharmaceutical industry?
The EDQM is an organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for medicines and their safe use.
What does EDQM stand for?
Quality of Medicines & HealthCare. Home. EDQM.
What is EDQM certificate of suitability?
The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).
What is the difference between a pharmacopeia and a monograph?
is that pharmacopoeia is an official book describing medicines or other pharmacological substances, especially their use, preparation, and regulation while monograph is a scholarly book or a treatise on a single subject or a group of related subjects, usually written by one person.
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.
What is CEP and DMF?
Active Substance Master File (ASMF) or Drug master file (DMF) or CEP is the set of series of information for an Active Pharmaceutical Ingredient (API) or Drug substance brought together in CTD format as per regulatory requirements.
What is the difference between Asmf and CEP?
CEP has many advantages when compared to ASMF, e.g.: CEP is not dependent on any MA. Unlike ASMFs, CEP is a stand-alone document reviewed by EDQM, whereas ASMFs can go through several assessments by different Member States. Additional question related to API are rarely raised when CEP is used.
What are the contents of monograph in pharmacopoeia?
Furthermore, a monograph contains detailed instructions for identification, purity tests and other specific tests to limit the amount of undesirable impurities, all of which may be used to verify common requirements by manufacturers and formulators concerned with the quality of their ingredients and products.
