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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Risk-based Methodology for Validation of Pharmaceutical Batch Processes

Frederick Wiles
PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 387-398; DOI: https://doi.org/10.5731/pdajpst.2013.00923
Frederick Wiles
ProPharma Group, Inc., 10975 Benson Dr. Suite 330, Corporate Woods Bldg. 12, Overland Park, Kansas 66210
ASQ CQE
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  • For correspondence: fred.wiles@propharmagroup.com
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References

  1. 1.↵
    FDA. Guidance for Industry. Process Validation: General Principles and Practices. Office of Communications, Division of Drug Information, Silver Spring, MD, 2011.
  2. 2.↵
    Automotive Industry Action Group, American Society for Quality Control, Supplier Quality Requirements Task Force. Fundamental Statistical Process Control: Reference Manual. AIAG: Southfield, MI, 1991.
  3. 3.↵
    1. Both D. R.
    Measuring Process Capability. Landmark Publishing, Inc.: Cedarburg, WI, 2001.
  4. 4.↵
    1. Wald A,
    2. Wolfowitz J.
    (1946). Tolerance limits for a normal distribution. Annals of Mathematical Statistics 1946, 17 (2), 208–215; http://projecteuclid.org/euclid.aoms/1177730981, retrieved October 30, 2012.
    OpenUrl
  5. 5.↵
    NIST/SEMATECH e-Handbook of Statistical Methods; http://www.itl.nist.gov/div898/handbook/prc/section2/prc254.htm, retrieved September 07, 2012.
  6. 6.↵
    1. Pyzdek T.
    The Six Sigma Handbook. McGraw-Hill Companies, Inc.: New York, 2000.
  7. 7.↵
    NIST/SEMATECH e-Handbook of Statistical Methods; http://www.itl.nist.gov/div898/handbook/pmc/section3/pmc32.htm, retrieved September 7, 2012.
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PDA Journal of Pharmaceutical Science and Technology: 67 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 4
July/August 2013
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Risk-based Methodology for Validation of Pharmaceutical Batch Processes
Frederick Wiles
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 387-398; DOI: 10.5731/pdajpst.2013.00923

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Risk-based Methodology for Validation of Pharmaceutical Batch Processes
Frederick Wiles
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 387-398; DOI: 10.5731/pdajpst.2013.00923
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Keywords

  • Process capability
  • Statistical confidence
  • Statistical coverage
  • Control Chart
  • PFMECA
  • Process validation
  • Risk-based.

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