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(2)Pharmacopoeias

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allelipraise's version from 2018-06-06 11:24

Section 1

Question Answer
Pharmacopoeias provide standards for pharmaceutical substances and medicinal products as tools in the regulation of the quality of medicines
USP-NFcontains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements
National and Regional PharmacopeiasCover medicines used in the relevant country or region
National and Regional PharmacopeiasAre legally binding “official” in the relevant country or region
USPmonographs for drug substances, dosage forms, and compounded preparations; also, for dietary supplements and ingredients
NFmonographs for excipients
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Section 2

Question Answer
Monographincludes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification (a series of tests, procedures for the tests, and acceptance criteria).
General Chaptersdescribe in detail tests and procedures referred to in multiple monographs
General Noticesprovide definitions for terms used in the monographs, as well as information that is necessary to interpret the monograph requirements.
Official ArticleArticle that is found in the current NF
Unofficial articleAn article that used to be official and is no longer found in the NF
Non-Offical articleAn article that was never written in the NF
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Section 3

Question Answer
British Pharmacopoeia (BP)the official, authoritative collection of standards for UK medicinal substances for human and veterinary use( updated annually)
European Pharmacopoeia (Ph. Eur.)defines requirements for the qualitative and quantitative composition of medicines (preparations of chemical, animal, human or herbal origin, homoeopathic preparations and homoeopathic stocks, antibiotics, biologicals, vaccines, radiopharmaceuticals), the tests to be carried out on medicines and on substances and materials used in their production
Japanese Pharmacopoeia (JP)first published in June 1886 and implemented in July 1887 by the Pharmaceuticals and Medical Devices Agency under the authority of the Ministry of Health, Labor and Welfare
Philippine Pharmacopoeia 1 (PP 1) the official book of standards for pharmaceutical products and crude plant drugs in the Philippines - contains the traditional medicines, clinical approach, diagnosis and management, traditional medicine council law, traditional practitioner's oath and ethics, common diseases encountered by TMPs, management of (5) common diseases, mostly prescribed traditional medicine formularities, medical records & referral system and mostly used medicinal plants
International Pharmacopoeia (Ph. Int.)constitutes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients, and dosage forms that is intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements
Philippine PharmacopeiaFirst published in 2004 under the proclamation of Executive Order No. 302
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