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Research ArticleTechnology/Application

Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies

Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler and Mahesh Shivhare
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 425-444; DOI: https://doi.org/10.5731/pdajpst.2020.011676
Nicolas Heigl
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
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Bernhard Schmelzer
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
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Franz Innerbichler
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
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Mahesh Shivhare
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
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  • For correspondence: M.R.Shivhare@gmail.com
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PDA Journal of Pharmaceutical Science and Technology: 75 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
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Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler, Mahesh Shivhare
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 425-444; DOI: 10.5731/pdajpst.2020.011676

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Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler, Mahesh Shivhare
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 425-444; DOI: 10.5731/pdajpst.2020.011676
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Keywords

  • Statistical process control
  • statistical quality control
  • biopharmaceutical process control
  • biopharmaceutical manufacturing
  • Biopharmaceuticals
  • control
  • chart

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