PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology
®
43
Qualit
y
t ional. Dec. 6, 2000. ht t ps://w w w.upi.com/A r-
chives/2000/12/06/ NHTSA-148-deat hs-lin ked-
to-Firestone-tires/4101976078800/
43. Kindy, K.; Sun, L. H.; and Crites, A. Compounding
Pharmacies Have Been Linked to Deaths, Illnesses
for Years. The Washington Post. Feb. 7, 2013. https://
w w w.washingtonpost.com/national/health-sci-
e n c e/c o m p o u n d i n g-p h a r m a c i e s -h a v e - b e e n-
linked-to-deaths-illnesses-for-years/2013/02/07/
5ba90132-6b19-11e2-ada3-d86a4806d5ee_stor y.
html
44. Valencia, M. J. NECC Technician Testifies of Com-
pounding Drugs, Without a License. Boston Globe.
Ja n. 19, 2017. ht t ps:// w w w.bos tong lobe.com/
metro/2017/01/19/necc-technician-testifies-com-
pounding-drugs-without-license/09DXljRBhNl-
trWluPndg2L/story.html
45. Picard, C. 20 Most Dangerous Toys of All Time.
goodhousekeeping.com, Aug. 29, 2018.
46. Fitzgerald, J. and Peltz, J. Did the Electrified Third
Rail Make Train Wreck Deadlier?. The Miami Her-
ald. Feb.6, 2015. https://www.miamiherald.com/
news/nation-world/national/article9480242.html
47. Rushe, D. BP Sues Halliburton for Deepwater Hori-
zon Oil Spill Clean-up Costs. The Guardian. Jan. 3,
2012. w w w.t heg u a rd i a n.com/ bu si ness/2012/
jan/03/bp-sues-halliburton-over-deepwater
48. Herkert, J.; Borenstein, J.; and Miller, K. The Boe-
i ng 737 M A X: Lessons for Engi neer i ng Et h ics.
Science and Engineering Ethics, 2020 26, 2957-2974.
https://www.doi.org/10.1007/s11948-020-00252-y
49. Hume, N.; Sanderson, H.; and White, E. BHP Calls
for Stringent Measures After Vale Dam Disaster.
Financial Times. Feb. 19, 2019. https://www.ft.com/
content/aa236f be-33ea-11e9-bd3a-8b2a211d90d5
50. Power, S. West Virginia Mining Disaster: Mine
Cited Repeatedly for Safet y. Wall Street Journal,
Eastern Edition. 2010.
51. McAteer, J. D. Scofield Disaster Reminds Us of Im-
portance of Mining Safety. The Salt Lake Tribune.
2000.
52. Barton, D., & Wiseman, M. Focusing Capital on
t he Long Ter m. Har vard Business Re view. 2014.
https://hbr.org/2014/01/focusing-capital-on-the-
long-term
53. Rappapor t, A. Ten Ways to Create Shareholder
Value. Harvard Business Review. 2006. https://hbr.
org/2006/09/ten-ways-to-create-sha reholder-
value
54. Temple Universit y School of Pharmacy, Qualit y
Assurance and Regulatory Affairs Department 2021.
55. International Leadership Forum, GPS (ISPE, May
2012).
56. PDA/FDA ICH Q10 Executive Management Work-
shop, September 2012.
57. Jornitz, M. W. A Review of the Aging Process and
Facilities Topic. PDA Journal of Pharmaceutical Sci-
ence and Technology, 2015 69(4), 553-556. http://doi.
org/10.5731/pdajpst.2015.01061
58. PDA. Points to Consider for Aging Facilities. 2017.
ht t ps://store.pda.org/ TableOf Contents/43534 _
TOC.pdf
59. FDA. Pharmaceutical Qualit y for the 21
st
Centur y:
A Risk-Based Approach P rogress Repor t. (2007).
https://www.fda.gov/about-fda/center-drug-eval-
uation-and-research-cder/pharmaceutical-quali-
ty-21st-century-risk-based-approach-progress-re-
port
60. Poska, R. Human Error and Retraining: An In-
ter view with Kevin O'Donnell, Ph.D., Irish Med-
ic i nes Boa rd. Jour nal of Validat ion Technology,
2010 16(3), 53-65. Retrieved July 13, 2021, from
ht t ps://w w w.proquest.com/openv iew/687fe1d-
d7e46a850f6d06625d8b4f878/1?pq-or igsite=g-
scholar&cbl=29232
61. Berry, C.; Chviruk, B.; Hernandez, D.; Beaugard,
M.; Stevens, K. B.; Polizzotto, J.; Bjerregaard, L.;
and Purbrick, D. What Does It Really Look Like
to Properly Address a "Human Error Problem" in
Biopharma? The Human Performance Blue-Sky
Description That Will Help Improve Industry Per-
formance. PDA Journal of Pharmaceutical Science
and Technology 2019 73(4), 391-400. https://doi.
org/10.5731/pdajpst.2018.00962
1
62. Wilson, A.; Moedler, M.; and McAuley, G. Chang-
ing the Performance Paradigm in Pharma/ Bio-
tech: Integrating Human Performance in Global
Organizations. PDA Journal of Pharmaceutical Sci-
ence and Technology, 2015 69(5), 658-665. https://
doi.org/10.5731/pdajpst.2015.01088
63. FDA. Pharmaceutical Quality for the 21st Century: A
Risk-Based Approach Progress Report. (FDA, 2007).
https://www.fda.gov/about-fda/center-drug-eval-
uation-and-research-cder/pharmaceutical-quali-
ty-21st-century-risk-based-approach-progress-re-
port
64. Ramnarine, E. and O'Donnell, K. ., PDA J Pharm
Sci Technol. online, May/June 2018. DOI: 10.5731/
pdajpst.2017.008524.
65. PIC/S. How to Evaluate and Demonstrate the Effec-
tiveness of a Pharmaceutical Quality System in rela-
tion to Risk-based Change Management (2021).
66. FDA. Q12 Technical and Regulatory Considerations
for Pharmaceutical Product Lifecycle Management
Guidance for Industry (CDER, CBER, May 2021).
67. FDA. SUPAC-IR: Immediate-Release Solid Oral Dos-
age For ms: Scale-Up and Post-Approval Changes:
Chemist r y, Manufactur ing and Cont rols, In Vit ro
Dissolution Testing, and In Vivo Bioequivalence Doc-
umentation (CDER, November 1995).
68. Woodcock, J. and Wosinka, M. Clin Pharmacol Ther.
online, (Nov. 7, 2012). DOI: 10.1038/clpt.2012.220.
