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Research ArticleTechnology/Application

An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes

Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand and Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 497-508; DOI: https://doi.org/10.5731/pdajpst.2021.012662
Jens Lamerz
1Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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  • For correspondence: jens.lamerz@roche.com
Oana Mihaela Danila
1Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Andreas Schuster
2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Janine Burren
1Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Christian Moessner
2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Wolfgang Göhring
2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Pankaj Rege
3Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Basel, Switzerland; and
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Helmut Stahr
2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Stefan Hildbrand
2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Daniel Coleman
4Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA, USA
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Article Information

vol. 76 no. 6 497-508
DOI 
https://doi.org/10.5731/pdajpst.2021.012662
PubMed 
35840347

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 2, 2022.

Article Versions

  • previous version (July 15, 2022 - 11:02).
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Copyright & Usage 
© PDA, Inc. 2022

Author Information

  1. Jens Lamerz1,*,
  2. Oana Mihaela Danila1,
  3. Andreas Schuster2,
  4. Janine Burren1,
  5. Christian Moessner2,
  6. Wolfgang Göhring2,
  7. Pankaj Rege3,
  8. Helmut Stahr2,
  9. Stefan Hildbrand2 and
  10. Daniel Coleman4
  1. 1Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
  2. 2Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
  3. 3Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Basel, Switzerland; and
  4. 4Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA, USA
  1. ↵*Corresponding Author: Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, Switzerland; Telephone: +41 79 751 72 89; E-mail: jens.lamerz{at}roche.com
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    Organic Process Research & Development 2024 28 5
  • QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters
    Pankaj D. Rege, Andreas Schuster, Jens Lamerz, Christian Moessner, Wolfgang Göhring, Pirmin Hidber, Helmut Stahr, Oana Mihaela Andrei, Janine Burren, Alexandre Moesching, Daniel Coleman, Stefan Hildbrand
    Organic Process Research & Development 2024 28 4
  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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PDA Journal of Pharmaceutical Science and Technology: 76 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 6
November/December 2022
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An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand, Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 497-508; DOI: 10.5731/pdajpst.2021.012662

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An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand, Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 497-508; DOI: 10.5731/pdajpst.2021.012662
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Methods: Motivation, Definitions, and Examples
    • 3. Discussion: IR Thresholds, CQA Acceptance Limits, and Interactions
    • 4. Application to a Drug Substance Process Step
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Keywords

  • Critical process parameter
  • Critical quality attribute
  • Critical quality attribute acceptance limits
  • Impact ratio
  • Impact ratio threshold

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