Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals

Evdokia Korakianiti; Dimitrios Rekkas

doi:10.1007/s11095-010-0315-3

Pharmaceutical Research

July 2011, Volume 28, Issue 7, pp 1465–1479

Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals

Authors
Authors and affiliations

Evdokia Korakianiti
Dimitrios RekkasEmail author

Expert Review

First Online:: 14 December 2010

Received:: 12 April 2010
Accepted:: 28 October 2010

16 Citations
1.1k Downloads

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.

KEY WORDS

design of experiments knowledge management process analytical technologies process variability quality quality by design statistical process control and analysis statistical thinking

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Authors and Affiliations

Evdokia Korakianiti
- 1
Dimitrios Rekkas
- 2
Email author

1.European Medicines AgencyQuality Sector, ChemicalsLondonUK
2.School of Pharmacy, Division of Pharmaceutical TechnologyUniversity of AthensAthensGreece

About this article

Cite this article as:: Korakianiti, E. & Rekkas, D. Pharm Res (2011) 28: 1465. doi:10.1007/s11095-010-0315-3

DOI 10.1007/s11095-010-0315-3
Publisher Name Springer US
Print ISSN 0724-8741
Online ISSN 1573-904X

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The American Association of Pharmaceutical Scientists

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