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Research ArticleTechnology/Application

A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry

Bert Gunter, Daniel Coleman, Aaron Goerke, Theo Koulis, Jens Lamerz and Yiming Peng
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 188-198; DOI: https://doi.org/10.5731/pdajpst.2017.008177
Bert Gunter
1Retired, formerly Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
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Daniel Coleman
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
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  • For correspondence: coleman.daniel@gene.com
Aaron Goerke
3Global Manufacturing Science and Technology, F. Hoffmann-La Roche AG, Basel, Switzerland; and
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Theo Koulis
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
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Jens Lamerz
4Nonclinical Biostatistics, F. Hoffmann-La Roche AG, Basel, Switzerland
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Yiming Peng
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
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Article Information

vol. 72 no. 2 188-198
DOI 
https://doi.org/10.5731/pdajpst.2017.008177
PubMed 
29242393

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online March 23, 2018.

Article Versions

  • previous version (December 14, 2017 - 17:10).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Bert Gunter1,
  2. Daniel Coleman2,*,
  3. Aaron Goerke3,
  4. Theo Koulis2,
  5. Jens Lamerz4 and
  6. Yiming Peng2
  1. 1Retired, formerly Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
  2. 2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
  3. 3Global Manufacturing Science and Technology, F. Hoffmann-La Roche AG, Basel, Switzerland; and
  4. 4Nonclinical Biostatistics, F. Hoffmann-La Roche AG, Basel, Switzerland
  1. ↵* Corresponding Author: Nonclinical Biostatistics, Genentech Inc., South San Francisco, CA. E-mail: coleman.daniel{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
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A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry
Bert Gunter, Daniel Coleman, Aaron Goerke, Theo Koulis, Jens Lamerz, Yiming Peng
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 188-198; DOI: 10.5731/pdajpst.2017.008177

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A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry
Bert Gunter, Daniel Coleman, Aaron Goerke, Theo Koulis, Jens Lamerz, Yiming Peng
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 188-198; DOI: 10.5731/pdajpst.2017.008177
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  • Article
    • Abstract
    • 1. Introduction and Context
    • 2. Rpk Objectives
    • 3. Some Basics On Statistical Quantiles
    • 4. Rpk Definition and Interpretation
    • 5. Product A—How To “Read” the Data Display (Figure 2)
    • 6. Product B—Drilling Down (Figures 3 and 4)
    • 7. Product C—Drilling Down (Figures 5 and 6)
    • 8. FAQS
    • 9. Summary
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
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Keywords

  • risk ranking
  • process performance
  • Process capability
  • Critical quality attribute
  • Specifications
  • continuous process improvement

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