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Research ArticleConference Report

Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171
Graham Cook
1Pfizer UK, Farnham, Surrey, UK;
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  • For correspondence: graham.cook@pfizer.com
Georges France
2Novartis Switzerland, and GSK Switzerland, Prangins (Nyon), Switzerland;
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Øyvind Holte
3Norwegian Medicines Agency, Oslo, Norway;
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Giampiero Lorenti
4Italian Medicines Agency, Rome, Italy; and
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David Tainsh
5GSK UK, Brentford, Middlesex, UK
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Abstract

This paper summarizes the discussions and insights gained from the key themes that emerged during the Quality by Design (QbD) Workshop held at the European Medicines Agency (EMA) offices in London, UK, on 28–29 January 2014. Industry and regulators shared practical experiences from six case studies (five approved small molecule products and one phase 3 biotechnological product) based on QbD submissions by five companies (AstraZeneca, GlaxoSmithKline, Novartis, NovoNordisk, and Pfizer).

The case studies covered a range of different development, regulatory submission, and post-approval aspects of QbD and were developed through confidential discussions between the company representatives and regulators. Key themes that emerged from the workshop discussions were: 1. presentation of information in submissions (development story and the presentation of information in marketing authorization applications; risk assessment and criticality); 2. development aspects (design space; use of models; control strategy); and 3. post-approval aspects (lifecycle management; dossier—quality system interactions; handling of deviations). Many aspects of QbD for biotechnological products are similar to small molecules, but there are some important differences highlighted in this paper.

The final section of the paper discusses some proposals for future developments to address the issues that were identified.

LAY ABSTRACT: This paper summarizes the discussions and insights gained from the key themes that emerged during the Quality by Design (QbD) Workshop held at the European Medicines Agency offices in London, UK, on 28–29 January 2014. Industry and regulators shared practical experiences from six case studies (five approved small-molecule products and one phase 3 biotechnological product) based on QbD submissions by five companies (AstraZeneca, GlaxoSmithKline, Novartis, NovoNordisk, and Pfizer).

The case studies covered a range of different development, regulatory submission, and post-approval aspects of QbD and were developed through confidential discussions between the company representatives and regulators. Key themes that emerged from the workshop discussions were: 1. presentation of information in submissions (development story and the presentation of information in marketing authorization applications; risk assessment and criticality); 2. development aspects (design space; use of models; control strategy); and 3. post-approval aspects (lifecycle management; dossier—quality system interactions; handling of deviations). Many aspects of QbD for biotechnological products are similar to small molecules, but there are some important differences highlighted in this paper.

The final section of the paper discusses some proposals for future developments to address the issues that were identified.

  • Quality by design (QbD)
  • European Medicines Agency (EMA) Workshop London 2014
  • Presentation of information
  • Submissions
  • Regulatory dossier
  • Development
  • Risk assessment
  • Criticality
  • Design space
  • Models
  • Control strategy
  • Post-approval
  • Lifecycle management
  • Quality system
  • Deviations
  • © PDA, Inc. 2016
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PDA Journal of Pharmaceutical Science and Technology: 70 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti, David Tainsh
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 163-176; DOI: 10.5731/pdajpst.2015.006171
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Keywords

  • Quality by Design (QbD)
  • European Medicines Agency (EMA) Workshop London 2014
  • Presentation of information
  • Submissions
  • Regulatory dossier
  • Development
  • Risk Assessment
  • Criticality
  • Design space
  • Models
  • control strategy
  • Post-approval
  • lifecycle management
  • Quality System
  • Deviations

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti, David Tainsh
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 163-176; DOI: 10.5731/pdajpst.2015.006171

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