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

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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.

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ACKNOWLEDGMENTS

The authors would like to thank Mr S. Politis M.Sc. for his useful contribution.

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Authors and Affiliations

  1. European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK

    Evdokia Korakianiti

  2. School of Pharmacy, Division of Pharmaceutical Technology, University of Athens, Panepistimiopolis, 15771, Athens, Greece

    Dimitrios Rekkas

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  1. Evdokia Korakianiti
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  2. Dimitrios Rekkas
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Correspondence to Dimitrios Rekkas.

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The views presented in this article are those of the authors and may not be understood or quoted as being made on behalf of the European Medicines Agency or reflecting the position of the Agency.

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Korakianiti, E., Rekkas, D. Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals. Pharm Res 28, 1465–1479 (2011). https://doi.org/10.1007/s11095-010-0315-3

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