caa a22 4500 445312173 CHVBK 20180317142634.0 cr unu---uuuuu 170323e20110701xx s 000 0 eng 10.1007/s11095-010-0315-3 doi (NATIONALLICENCE)springer-10.1007/s11095-010-0315-3 Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals [Elektronische Daten] [Evdokia Korakianiti, Dimitrios Rekkas] ABSTRACT: 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. Springer Science+Business Media, LLC, 2010 design of experiments nationallicence knowledge management nationallicence process analytical technologies nationallicence process variability nationallicence quality nationallicence quality by design nationallicence statistical process control and analysis nationallicence statistical thinking nationallicence Korakianiti Evdokia European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK aut Rekkas Dimitrios School of Pharmacy, Division of Pharmaceutical Technology, University of Athens, Panepistimiopolis, 15771, Athens, Greece aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/7(2011-07-01), 1465-1479 0724-8741 28:7<1465 2011 28 11095 https://doi.org/10.1007/s11095-010-0315-3 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0315-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Korakianiti Evdokia European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK aut NATIONALLICENCE 700 1- Rekkas Dimitrios School of Pharmacy, Division of Pharmaceutical Technology, University of Athens, Panepistimiopolis, 15771, Athens, Greece aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/7(2011-07-01), 1465-1479 0724-8741 28:7<1465 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer