Pharmaceutical Technology - January 2024

Pharmaceutical Technology - January 2024

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42 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y fda.gov/media/71553/download 15. FDA, P rocess Validation: General P r inciples and Practices Guidance for Industry (CVM, CDER, CBER, January 2011). 16. Coccia, M. Measuring the impact of sustainable technological innovation. International Journal of Technology Intelligence and Planning, 2009 5(3). http://doi.org/10.1504/IJTIP.2009.026749 17. Ball, K. Greener by Design - Contract Pharma. Pfizer CentreOne. (2020). https://www.pfizercentreone. com/ i n s i g ht s-r e s ou r ce s/a r t ic le s/g r e e ne r- de - sign-contract-pharma 18. Kramer, M. R. and Pfitzer, M. W. Ecosystems of Shared Value. Har vard Business Review, 2016 80- 89. ht t ps:// hbr.org/2016/10/t he-ecos ystem-of- shared-value 19. White, A.; Johnson, M.; and Wilson, H. RFID in the supply chain: lessons from European early adopt- ers. International Journal of Physical Distribution & Logistics Management, 2008 38(2), 88-107. https:// doi.org/10.1108/09600030810861189 20. Lee, S. M.; Olsen, D. L.; and Trim i, S. Co-in no- v at ion: Conver genom ic s, Col l abor at ion , a nd Co-creation for Organizationa l Va lue. Manage- ment Decision , 2012 50(5), 817-831. ht t ps://doi. org/10.1108/00251741211227528 21. Lee, S. M. and Trimi, S. Innovation for creating a sm a r t f ut u re. Jour nal of Innovat ion & Knowl- edge , 2018 3(1), 1-8. ht t ps://doi.org/10.1016/j. jik.2016.11.001 22. Brust, P. J. and Gyrna, F. M. Quality And Econom- ics: Five Key Issues. Quality Progress, 2002 35(10), 64-69. (accessed July 12, 2021). https://asq.org/ qua lit y-progress/ar ticles/qua lit y-and-econom- ics-five-key-issues?id=f0388a05587c4f b5a4bff22f- 0c2f3b22 23. M aubou ssi n , M. J. T he Tr ue Mea s u re of Suc- cess. Har vard Business Review. 2012. https://hbr. org/2012/10/the-true-measures-of-success 24. American Society for Quality. 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M a n d a l , P. I m p r o v i n g P r o c e s s I m p r o v e - m e n t : E x e c u t i n g t h e A n a l y z e a n d I m pr o v e Pha ses of DM A IC Bet ter. Inter nat ional Jour nal of Lean Six Sigma, 2012 3(3), 231-250. http://doi. org/10.1108/20401461211282727 34. Kramer, M. R. and Pfitzer, M. W. Ecosystems of Shared Value. Har vard Business Review, 2016 80- 89. ht t ps:// hbr.org/2016/10/t he-ecos ystem-of- shared-value 35. Friedman, R. L. J. Valid. Technol. (2015). 36. Friedman R. L. and Mahoney, S.C. Am. Pharm. Rev. 2003 6 (1) 44-47 37. Guilfoyle D. E. et al., PDA J Pharm Sci Technol. on- line, DOI: 10.5731/pdajpst.2013.00915 (March/April 2013). 38. Friedman, R.L. PDA J Pharm Sci Technol. 2005 59 (2) 118-126. 39. Suvarna, K.; Lolas, A.G.; Hughes, P.F. and Fried- man, R.L. Am. Pharm. Rev. 2011 14 (1) 50. 40. Gomez, M. A., Byers, E. J., Stingley, P., Sheridan, R. M., & Hirsch, J. A. Establishing Operational Sta- bility–Developing Human Infrastructure. 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