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The European Pharmacopoeia Commission determines the general principles applicable to the elaboration of the European Pharmacopoeia. It also decides the work programme, sets up and appoints experts to the specialised groups responsible for preparing monographs, adopts these monographs, and recommends dates for the implementation of its ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use.
Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products. Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary. Regulate clinical trials of medicines and medical devices.
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom.It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
World Health Organization building from the South-East, Geneva The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization [1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, [2] together with supporting ...
British Pharmacopoeia; European Pharmacopoeia; Japanese Pharmacopoeia; The International Pharmacopoeia; United States Pharmacopeia; If any pharmaceutical product is not covered by the above standards, it can be evaluated by the additional source of pharmacopoeias from other nations, from industrial specifications, or from a standardized ...