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

Nicolas Heigl; Bernhard Schmelzer; Franz Innerbichler; Mahesh Shivhare

doi:10.5731/pdajpst.2020.011676

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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vol. 75 no. 5 425-444

DOI

https://doi.org/10.5731/pdajpst.2020.011676

PubMed

33723005

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online September 27, 2021.

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previous version (March 15, 2021 - 05:58).
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Nicolas Heigl,
Bernhard Schmelzer,
Franz Innerbichler and
Mahesh Shivhare*

Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria

↵*Corresponding Author: 6 Falcon Way, Shire Park, Welwyn Garden City, AL71TW, United Kingdom. Telephone: +44 (0) 7717 857693; E-mail: M.R.Shivhare{at}gmail.com

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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
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