Document Detail


Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals.
MedLine Citation:
PMID:  21161338     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The purpose of this article is to present the evolution of quality principles and how they have been implemented in the pharmaceutical industry. The article discusses the challenges that the FDA PAT Guidance and the ICH Q8, Q9 and Q10 Guidelines present to industry and provides a comprehensive overview of the basic tools that can be used to effectively build quality into products. The principles of the design of experiments, the main tools for statistical process analysis and control, and the requisite culture change necessary to facilitate statistical, knowledge-based management are also addressed.
Authors:
Evdokia Korakianiti; Dimitrios Rekkas
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2010-12-14
Journal Detail:
Title:  Pharmaceutical research     Volume:  -     ISSN:  1573-904X     ISO Abbreviation:  -     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8406521     Medline TA:  Pharm Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK.
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