Pharmaceutical Technology - January 2024

Pharmaceutical Technology - January 2024

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44 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y 69. Woodcock, J. PDA J Pharm Sci Technol. online (May/ June 2012), DOI: 10.5731/pdajpst.2012.00874. 70. FDA. Drug Shortages: Root Causes and Potential Solu- tions (2020). https://www.fda.gov/media/131130/ download 71. American Society for Quality. (n.d.). Qualit y Re- sources: Cost of Quality (COQ). ASQ. https://asq.org/ quality-resources/cost-of-quality 72. Patel, P.; Baker, D.; Burdick, R.; Chen, C.; Hill, J.; Holland, M.; and Sawant, A. Quality Culture Sur- vey Report. PDA Journal of Pharmaceutical Science and Technology, 2015 69(5), 631-642. https://doi. org/10.5731/pdajpst.2015.01078 73. Gieske, H.; Buu ren , A. V.; Bek kers, V. J. J. M. Conceptualizing Public Innovative Capacit y: A Framework for Assessment. Innovation Journal, 2016. 21(1).(accessed July 13, 2021), https://www.re- searchgate.net/publication/302900973_Concep- tualizing _ public_innovative_capacity _A_frame- work_for_assessment 74. Lee, S. M. and Trimi, S. Innovation for Creating a Sma r t Fut 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 75. Kramer, M. R. and Pfitzer, M. W. Ecosystems of Shared Value. Harvard Business Review, 2016. 80- 89. ht t ps:// hbr.org/2016/10/t he-ecos ystem-of- shared-value 76. D e d e h ay i r, O.; O r t t , R . J.; R i ve r ol a , C .; a n d M i r a l les, F. C h apter 4: I n nov ator s a nd E a rly Adopters in the Diff usion of Innovations: A Lit- erat ure Rev iew. Inter national Jour nal of Innova- t ion Management , 2019 21(8), 1-27. ht t ps://doi. org/10.1142/9781786347602_0004 77. Dorn, E.J.; Frantz, J. J.; and Valerio, P. F. 2020 ISPE Barrier Sur vey: Tracking the Journey of Barrier Technology. ispe.org, July/August 2020. 78. Rogers, E. M. Diffusion of Innovations (Free Press, New York, 5th ed., 2003). 79. Perrow, C. Bulletin of the Atomic Scientists. online, (Nov. 27, 2015). DOI: 10.1177/0096340211426395. 80. P fat teicher, S. K. A. Jour nal of Per for mance of C o n s t r u c t e d F a c ilit i e s . on l i n e , D OI: 10.10 61/ (ASCE)0887-.May 1, 2000 3828(2000)14:2(62). 81. Page, T.; Dubina, H.; Fillipi, G.; Guidat, R.; Patnaik, S.; Poechlauer, P.; Shering, P.; Guinn, M.; Mcdon- nell, P.; and Johnston, C. Equipment and Analyt- ical Companies Meeting Continuous Challenges. May 20–21, 2014 Continuous Manufacturing Sym- posium. Journal of Pharmaceutical Sciences, 2015. 104(3), 821-831. https://doi.org/10.1002/jps.24282 82. Szymczak, M. M.; Friedman, R. L.; Uppoor, R.; and Yacobi, A. Detection, Measurement, and Control in Pharma Manufacturing: PQRI-FDA Workshop Summar y on Process Drift. Pharmaceutical Tech- nology, 2011. 70-76. (accessed July 13, 2021). https:// pqri.org/wp-content/uploads/2015/08/pdf/Pro- cessDrift-Final-article.pdf 83. ICH. ICH Q9 EWG Training Slides: Availability. ich. org. 84. Crosby, P.B. Quality Is Free: The Art of Making Qual- ity Certain (1 st ed.). McGraw-Hill. (1979). 85. Friedli, T.; Kickuth, M.; Stieneker, F.; Thaler, P.; and Werani, J. Operational Excellence in the Phar- maceutical Industr y (1 st ed.). Editio Cantor Verlag. (2016). 86. Davis, J. R. and Atkinson, T. Need Speed? Slow Down. Harvard Business Review. 2010. https://hbr. org/2010/05/need-speed-slow-down 87. Miller, O. W.; Chou, Kuo-Chong; Chang, C. Alec Case Study: Use of the Taguchi Loss Function (1989, ASQC). 88. Paulk, M.C.; Weber, C. V.; Curtis, B.; and Chrissis, M., B. The Capability Maturity Model: Guidelines for Improving the Software Process (1 st ed.). Carne- gie Mellon University Software Engineering Insti- tute, Addison-Wesley Professional. (1994). 89. McK i n sey & Compa ny. F lawless: From measur- ing failure to building quality robustness in pharma. McKinsey & Company. Feb. 1, 2015. https://www. mckinsey.com/~/media/mckinsey/dotcom/client_ service/operations/pdfs/f lawless_from_measur- ing _failure_to_building _quality _robustness_in_ pharma_intro_chapter.ashx 90. Schiffauerova, A. and Thomson, V. A review of research on cost of quality models and best prac- tices. International Journal of Quality & Reliability Management, 2006 23(6), 647-669. ht t ps://doi. org/10.1108/02656710610672470 91. Chenge, M-H and Rosentrater, K. A. Economic Feasibility Analysis of Soybean Oil Production by Hexane Extraction. Industrial Crops and Products, 2017. 108, 775-785. https://doi.org/10.1016/j.ind- crop.2017.07.036 92. Sparling, D. H. and Sterling, B. Food Traceability: Understanding the Business Value. ResearchGate. (2014). (accessed July 12, 2021) ht t ps://w w w.re- searchgate.net/publication/264878496_FOOD_ TRACEABILIT Y_UNDERSTANDING_THE _BUSI- NESS_VALUE 93. Barosz, P.; Golda, G.; and Kampa, A. Efficiency A n a ly si s of M a nu f ac t u r i n g L i ne w it h I ndu s- trial Robots and Human Operators. Applied Sci- ences, 2020. 10(8), 2862. https://doi.org/10.3390/ app10082862 94. Beauvais, B.; Richter, J. P.; Kim, F. S.; Sickels, G.; Hook, T.; Kiley, S.; and Horal, T. Does Patient Safety Pay? Evaluating the Association Between Surgical Care Improvement Project Performance and Hos- pital Profitabilit y. Journal of Healthcare Manage- ment, 2019 64(3), 142-154. http://doi.org/10.1097/ JHM-D-17-00208

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