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  3. Medical: Pharmaceuticals

monografia farmacopeica

English translation: pharmacopeial monograph

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Portuguese term or phrase:monografia farmacopeica
English translation:pharmacopeial monograph
Entered by: Lilian Magalhães

11:31 Dec 7, 2016
Portuguese to English translations [PRO]
Medical - Medical: Pharmaceuticals / anvisa
Portuguese term or phrase: monografia farmacopeica
Não é permitida a adoção mista ou incompleta de monografias farmacopeicas para um ativo, excipiente ou produto acabado. Portanto, uma vez que uma farmacopeia é utilizada como referência para o controle de qualidade de um princípio ativo, excipiente ou produto acabado, todos os testes preconizados neste compêndio devem ser realizados.
Contudo, uma vez adotada uma farmacopeia reconhecida pela Agência na íntegra, é permitida a complementação de um ou mais testes, utilizando outra farmacopeia.
Lilian Magalhães
Brazil
Local time: 09:59
pharmacopeial monograph
Explanation:
https://www.google.com.br/search?q="pharmocopeic monograph"&...


https://en.wikipedia.org/wiki/Monograph
In United States Food and Drug Administration regulation
See also: Pharmacopoeia

In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products."[6] Such usage has given rise to the use of the word monograph as a verb, as in "this substance has been monographed by the FDA".
Selected response from:

Gilmar Fernandes
United States
Local time: 08:59
Grading comment
grata, mestre
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2pharmacopeial monograph
Gilmar Fernandes
4 +1pharmacopoeial monographs
Bruno Michel (X)
Summary of reference entries provided
see
liz askew

  

Answers


13 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
pharmacopeial monograph


Explanation:
https://www.google.com.br/search?q="pharmocopeic monograph"&...


https://en.wikipedia.org/wiki/Monograph
In United States Food and Drug Administration regulation
See also: Pharmacopoeia

In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products."[6] Such usage has given rise to the use of the word monograph as a verb, as in "this substance has been monographed by the FDA".

Gilmar Fernandes
United States
Local time: 08:59
Native speaker of: Native in PortuguesePortuguese, Native in EnglishEnglish
PRO pts in category: 54
Grading comment
grata, mestre

Peer comments on this answer (and responses from the answerer)
agree  Rafael Sousa Brazlate
4 hrs
  -> Valeu, Rafa :)
agree  Mario Freitas:
14 hrs
  -> Thanks Mario :) Um bom feriado em BH!
Login to enter a peer comment (or grade)

13 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
pharmacopoeial monographs


Explanation:
http://www.usp.org/usp-nf/harmonization

https://en.wikipedia.org/wiki/Pharmacopoeia

https://scholar.google.com.br/scholar?q=pharmacopoeial monog...

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Note added at 20 mins (2016-12-07 11:52:18 GMT)
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USP Harmonized Pharmacopeial Monographs
PDG Purpose
The purpose of PDG is to harmonize pharmacopeial standards (excipient monographs and selected general chapters) in three major regions of the world. Harmonization reduces manufacturers' burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopeial requirements that vary across regions. At all times, PDG strives to maintain a consistent level of science across the three pharmacopoeias, with the shared goal of protecting the public health. A pharmacopeial monograph for an active ingredient or excipient, preparation, or other substance used in the manufacture or compounding of a medicinal product generally provides a specification by way of a name, definition, description, tests, procedures, and acceptance criteria and sometimes packaging, labeling, and storage statements. For frequently cited procedures, or for broad-based guidance, a monograph may reference a general chapter.

http://www.usp.org/usp-nf/harmonization

Bruno Michel (X)
Brazil
Local time: 09:59
Native speaker of: Portuguese

Peer comments on this answer (and responses from the answerer)
agree  Clécio Santos
4 hrs
  -> Obrigado.
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Reference comments


58 mins
Reference: see

Reference information:
How are Pharmacopoeial monographs written, interpreted and ...
https://www.raci.org.au/document/item/2056
Overview. • How to read and interpret monographs. – The format and style of monographs. – How to interpret. • When you have a different impurity profiles.

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Note added at 1 hr (2016-12-07 12:33:43 GMT)
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Pharmacopeial
319,000 result

Pharmacopoeial

189,000


much will depend on the target country

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 60
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