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Article CommentaryCommentary

Enabling ICH Q10 Implementation—Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9

Nuala Calnan, Kevin O'Donnell and Anne Greene
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 581-600; DOI: https://doi.org/10.5731/pdajpst.2013.00940
Nuala Calnan
1School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Dublin, Ireland; and
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  • For correspondence: nuala.calnan@mydit.ie
Kevin O'Donnell
2Irish Medicines Board, Bord Leigheasra na hÉireann, Dublin, Ireland
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Anne Greene
1School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Dublin, Ireland; and
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References

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PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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Enabling ICH Q10 Implementation—Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9
Nuala Calnan, Kevin O'Donnell, Anne Greene
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 581-600; DOI: 10.5731/pdajpst.2013.00940

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Enabling ICH Q10 Implementation—Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9
Nuala Calnan, Kevin O'Donnell, Anne Greene
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 581-600; DOI: 10.5731/pdajpst.2013.00940
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    • Abstract
    • 1 Introduction
    • 2 Pharmaceutical Quality System (PQS) Implementation within Commercial Manufacturing
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Keywords

  • The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • ICH Q8 (R2) Product Development
  • ICH Q9 Quality Risk Management (QRM)
  • ICH Q10 Pharmaceutical Quality System (PQS)
  • Implementation
  • Operational excellence
  • Six sigma
  • Lean manufacturing
  • innovation
  • Continual improvement
  • Senior and corporate management responsibilities
  • Leadership
  • Regional regulatory enforcement
  • Knowledge creation and management.

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