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International Pharmaceutical Excipients Council is a global organization founded in 1991 representing producers, suppliers, and end users of excipients. The body has three divisions in Europe , Japan , and the United States , each of which focuses on local regulations concerning the excipients market, as well as on new research and business ...
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
This is a list of published [note 1] standards and other deliverables of the International Organization for Standardization (ISO). [note 2] For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. [1] The standards are protected by copyright and most of them must be purchased.
ISO/HL7 27932:2009 Data Exchange Standards – HL7 Clinical Document Architecture, Release 2; ISO/HL7 27951:2009 Health informatics – Common terminology services, release 1; ISO/HL7 27953 Health informatics – Individual case safety reports (ICSRs) in pharmacovigilance ISO/HL7 27953-1:2011 Part 1: Framework for adverse event reporting
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]