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PDA Journal of Pharmaceutical Science and Technology

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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
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References

  1. 1.↵
    ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8(R2), current step 4 version dated August 2009.
  2. 2.↵
    1. Kotz S.,
    2. Johnson N. L.
    Process Capability Indices; Chapman & Hall: New York, 1993.
  3. 3.↵
    1. Hyndman R. J.,
    2. Fan Y.
    Sample Quantiles in Statistical Packages. The American Statistician 1996, 50 (4), 4.
    OpenUrl
  4. 4.↵
    1. Tukey J. W.
    Exploratory Data Analysis, 1st ed.; Addison-Wesley: Boston, MA, 1977.
  5. 5.↵
    1. Montgomery D. C.
    Introduction to Statistical Quality Control, 6th ed.; John Wiley & Sons: Hoboken, NJ, 2009.
  6. 6.↵
    1. Gunter B. H.
    The Use and Abuse of Cpk, Part 2. Quality Progress 1989, 22 (3), 108–109.
    OpenUrl
  7. 7.↵
    1. Somerville S. E.,
    2. Montgomery D. C.
    Process Capability Indices and Non-Normal Distributions. Quality Engineering 1997, 9 (2), 305–316.
    OpenUrl
  8. 8.↵
    1. Vannman K.,
    2. Albing M.
    Process Capability Indices for One-Sided Specification Intervals and Skewed Distributions. Quality and Reliability Engineering International 2007, 23 (6), 755–765.
    OpenUrl
  9. 9.↵
    1. Clements J. A.
    Process capability calculations for non-normal distributions. Quality Progress 1989, 9.
  10. 10.↵
    1. Pal S.
    Evaluation of Non-Normal Process Capability Indices Using Generalized Lambda Distribution. Quality Engineering 2005, 17 (1), 77–85.
    OpenUrl
  11. 11.
    1. Chen J. P.,
    2. Ding C. G.
    A New Process Capability Index for Non-Normal Distributions. International Journal of Quality & Reliability Management 2001, 18 (7), 762–770.
    OpenUrlCrossRef
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In This Issue

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
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Keywords

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

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