10 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m
tools (e.g., by creating small pilot projects to dem-
onstrate the benefit of a specific technology). With
artificial intelligence, for instance, a lot of the cod-
ing needed to build solutions is open source and
doesn't cost a lot," she says.
Overall, training will be crucial to building a
culture of quality. "People come to work wanting
to do the right thing. It is all how managers send
the message down and how they create an envi-
ronment of trust. That is really the bottom line,"
she says.
References
1. FDA, Quality Metrics for Drug Manufacturing, fda.gov, October
7, 2018, www.fda.gov/drugs/pharmaceutical-quality-resources/
quality-metrics-drug-manufacturing
2. A. Harrison and S. Schniepp, PharmTech 39(9) pp. 22-25 (2015).
3. S. Caramela, "The Management Theory of Peter Drucker,"
business.com, Feb. 27, 2018, www.business.com/articles/man-
agement-theory-of-peter-drucker/
4. T. Friedli et al, PDA Journal 72(5), pp. 531-542, September 2018
5. A. Srinavasan and B. Karey, "Creating a Culture of Quality,"
hbr.org, April 2014, https://hbr.org/2014/04/creating-a-culture-
of-quality.
6. M. Kimes, "Why J&J's Headache Won't Go Away," fortune.com,
August 19, 2010, https://archive.fortune.com/2010/08/18/news/
companies/jnj_drug_recalls.fortune/index.htm
7. W. Adis, "McNeil, a J&J Subsidiary FDA Case Study," Commu-
nications of the International Information Management Associa-
tion (IIMA), 14 (3), Article 2, https://scholarworks.lib.csusb.
edu/cgi/viewcontent.cgi?referer=https://www.google.com/&htt
psredir=1&article=1359&context=ciima
8. E. Palmer, "Mylan Fired Workers at Agila Plant," fiercepharma.
com, June 27, 2016.
9. FDA, Warning Letter, Strides Pharma Science Ltd., fda.gov, July
1, 2019, www.fda.gov/inspections-compliance-enforcement-
and-criminal-investigations/warning-letters/strides-pharma-
science-limited-576722-07012019
10. Shanley, A., Pharm. Tech. 2016 Supplement Issue 2 pp s40-s44,
www.pharmtech.com/offshore-supplier-quality-trust-
verify?pageID=2
11. Harvard Business Review ideacast, Creating Psychological
Safety in the Workplace, an Interview with Amy Edmonson,
hbr.org, January 22, 2019, https://hbr.org/ideacast/2019/01/cre-
ating-psychological-safety-in-the-workplace
12. J. Macher, "Business Case for Quality, a presentation at the
Pharma Quality Systems," ICH Q10 Conference, October 4-6,
2011, www.fda.gov/media/82992/download
13. R. Kegan, In Over Our Heads: The Mental Demands of Mod-
ern Life (Harvard University Press, 1994).
PT
Quality Compliance
♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦
♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦ CALL FOR PAPERS ♦
Pharmaceutical Technology and Pharmaceutical Technology Europe cover
all aspects of pharmaceutical drug development and manufacturing,
including formulation development, process development and
manufacturing of active pharmaceutical ingredients (both small molecule
and large molecules) and finished drug-products (solid dosage, semisolid,
liquids, parenteral drugs and topical drugs), drug-delivery technologies,
analytical methods development, analytical testing, quality assurance/
quality control, validation and advances in pharmaceutical equipment,
machinery, instrumentation, facility design and plant operations.
We are currently seeking novel research articles for our peer-reviewed
journal as well as manuscripts for our special issues. For peer-reviewed papers, members of the Editorial Advisory Board of
Pharmaceutical Technology and Pharmaceutical Technology Europe and other industry experts review manuscripts on technical and
regulatory topics. The review process is double-blind. Manuscripts are reviewed on a rolling basis.
Our single-themed issues, which include literature reviews and tutorials, address excipients and ingredients, analytical testing,
outsourcing, solid dosage and more.
Please visit our website, www.PharmTech.com/pharmtech-author-guidelines-and-editorial-calendars, to view our full Author
Guidelines. Manuscripts may be sent to Editorial Director Rita Peters at RPeters@mmhgroup.com.
We look forward to hearing from you.
Martin
Barraud/OJO
Images/Getty
Images
