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- Published online April 1, 2021.
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- previous version (September 30, 2020 - 13:07).
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- 1Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark;
- 2Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany;
- 3Porton Biopharma Ltd, Manor Farm Road, Porton Down, Salisbury, Wiltshire SP4 0JG, United Kingdom;
- 4Novo Nordisk A/S, Denmark; and
- 5Biocon Biologics India Ltd, 20th KM, Hosur Road, Electronic City, Bangalore 560100, India
- ↵* Corresponding Author: Frankfurter Straße 250, 64293 Darmstadt, Germany; Telephone: +49 (0) 6151 72-8337; E-mail: heribert.dahmen{at}merckgroup.com
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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
- Info & Metrics
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