Document Detail


International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice.
MedLine Citation:
PMID:  12358036     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  66     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2001 Sep 
Date Detail:
Created Date:  2002-10-01     Completed Date:  2002-10-11     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  49028-9     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
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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