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WHO Expert Committee on Specifications for Pharmaceutical Preparations.
MedLine Citation:
PMID:  22894011     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  World Health Organization technical report series     Volume:  -     ISSN:  0512-3054     ISO Abbreviation:  World Health Organ Tech Rep Ser     Publication Date:  2012  
Date Detail:
Created Date:  2012-08-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7903212     Medline TA:  World Health Organ Tech Rep Ser     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  1-235, back cover     Citation Subset:  IM    
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