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ISO 9001:2015 vs ICH Q10 - A Comparison

Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology September 2020, pdajpst.2020.011692; DOI: https://doi.org/10.5731/pdajpst.2020.011692
Carsten Aaberg
1 Novo Nordisk A/S;
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  • For correspondence: caa@novonordisk.com
Heribert Dahmen
2 Merck KGaA;
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  • For correspondence: heribert.dahmen@merckgroup.com
Cledwyn Davies
3 Porton Biopharma Ltd;
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  • For correspondence: cledwyn.davies@portonbiopharma.com
Pia Lise Sandau
1 Novo Nordisk A/S;
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  • For correspondence: pls@novonordisk.com
Raman Srinivasan
4 Biocon Biologics India Ltd
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  • For correspondence: srinivasan.raman@biocon.com
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Article Information

pdajpst.2020.011692
DOI 
https://doi.org/10.5731/pdajpst.2020.011692
PubMed 
32999074

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received May 11, 2020
  • Accepted August 24, 2020
  • Published online September 30, 2020.

Copyright & Usage 
Copyright © 2020, Parenteral Drug Association

Author Information

  1. Carsten Aaberg1 (caa{at}novonordisk.com),
  2. Heribert Dahmen2,5 (heribert.dahmen{at}merckgroup.com),
  3. Cledwyn Davies3 (cledwyn.davies{at}portonbiopharma.com),
  4. Pia Lise Sandau1 (pls{at}novonordisk.com) and
  5. Raman Srinivasan4 (srinivasan.raman{at}biocon.com)
  1. 1 Novo Nordisk A/S;
  2. 2 Merck KGaA;
  3. 3 Porton Biopharma Ltd;
  4. 4 Biocon Biologics India Ltd
  1. ↵* Corresponding author; email: heribert.dahmen{at}merckgroup.com

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PDA Journal of Pharmaceutical Science and Technology: 75 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 1
January/February 2021
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ISO 9001:2015 vs ICH Q10 - A Comparison
Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau, Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology Sep 2020, pdajpst.2020.011692; DOI: 10.5731/pdajpst.2020.011692

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ISO 9001:2015 vs ICH Q10 - A Comparison
Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau, Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology Sep 2020, pdajpst.2020.011692; DOI: 10.5731/pdajpst.2020.011692
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Keywords

  • ICH Q10
  • ISO 9001:2015
  • pharmaceutical quality system
  • quality management system

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