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Review ArticleReview

ISO 9001:2015 Versus ICH Q10 — A Comparison

Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692
Carsten Aaberg
1Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark;
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Heribert Dahmen
2Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany;
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  • For correspondence: heribert.dahmen@merckgroup.com
Cledwyn Davies
3Porton Biopharma Ltd, Manor Farm Road, Porton Down, Salisbury, Wiltshire SP4 0JG, United Kingdom;
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Pia Lise Sandau
4Novo Nordisk A/S, Denmark; and
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Raman Srinivasan
5Biocon Biologics India Ltd, 20th KM, Hosur Road, Electronic City, Bangalore 560100, India
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 75 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
March/April 2021
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ISO 9001:2015 Versus ICH Q10 — A Comparison
Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau, Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 188-206; DOI: 10.5731/pdajpst.2020.011692
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  • Article
    • Abstract
    • Introduction
    • History and Origin of ISO 9001 and ICH Q10
    • Commonality and Variance of ISO 9001 Versus ICH Q10—General Consideration
    • ISO 9001:2015 Changes from the 2008 to the 2015 Version
    • Detailed Assessment of the Changes to ISO 9001 and the Potential Impact on ICH Q10
    • Summary and Conclusions and Recommendations
    • Conflict of Interest Statement
    • Acknowledgements
    • Appendix
    • References
  • Figures & Data
  • References
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  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

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

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ISO 9001:2015 Versus ICH Q10 — A Comparison
Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau, Raman Srinivasan
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 188-206; DOI: 10.5731/pdajpst.2020.011692

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