| International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice. | |
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MedLine Citation:
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PMID: 12358036 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (APIs). The guidance is intended to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 66 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2001 Sep |
Date Detail:
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Created Date: 2002-10-01 Completed Date: 2002-10-11 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 49028-9 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Canada Congresses as Topic Drug Compounding / standards* Drug Industry / standards European Union Guidelines as Topic* Humans International Cooperation* Japan Quality Control United States United States Food and Drug Administration* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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