This issue highlights a variety of voices and points of view on matters ranging from sustainability to serialization, Pharma 4.0 to viral contamination, and EMA’s new location to game theory. In our cover story, Scott Fotheringham, PhD, interviews industry insiders to get their take on the sustainable use and reuse of water in pharmaceutical manufacturing plants.
Our editorials continue to provide food for thought: Board Chair Tim Howard reflects on achievements during the first quarter of 2018, International YP Chair Caroline Rocks shares her experiences with travel as professional development, and Pharmaceutical Engineering Committee (PEC) member Nissan Cohen argues for zero liquid discharge and a sustainable approach to water wastage and effluents in biopharmaceutical production.
Our first feature is the 2017 Roger F. Sherwood Article of the Year Award, “A Holistic Production Model: From Industry 4.0 to Pharma 4.0,” from the July-August 2017 issue of this magazine. The article is the first in the award’s history in which the judges’ decision was unanimous. This speaks to the strategic thinking showcased in the article: equal parts innovation, pragmatism, and measurable goals. Heartfelt congratulations to the authors: Prof. Dr. Cristoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD.
Our second feature is my interview with Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, whose keynote at ISPE’s 2017 Annual Meeting & Expo made the case for bringing “outsiders” into pharma to jump-start innovative thinking in manufacturing. Jim Breen adds a sidebar about “embracing innovation” and why building facilities of the future is the only way forward.
Technical articles run the gamut from regulatory compliance to product development. Arjun Guha Thakurta presents a case study on India’s experience with serialization; Brent Harrington and his team discuss the analytical target profile; Thomas R. Spearman and Daniel C. Carroll evaluate terminal HEPA filter maintenance programs in parenteral manufacturing plants; and Anne Stokes, PhD, discusses a risk-managed approach for managing potential virus and TSE contamination in cGMP biopharmaceutical facilities.
Risk-taking, original thinking, and solid technical information abound in this issue; I hope you find its articles relevant to the work you do. We aim to please, but if you have a differing point of view, let us know. We want to pursue conversations, even the difficult ones, in the pages of Pharmaceutical Engineering.
And here is one such conversation, albeit one-sided: This is my last issue as Editor in Chief, and I would like to say thank you to the members of the Pharmaceutical Engineering Committee and the legion of collaborators, authors, and reviewers who have helped make Pharmaceutical Engineering the standout magazine it is today. I have learned a great deal from each of you, and I don’t think I have ever met a more passionate group of engineers, or one whose members contribute so much time to supporting one another as well as the industry. I bow my head to you all.
We welcomed 2023 with high hopes and dreams of what Women in Pharma® could eventually be. As I prepare to conclude my time as the Chair of ISPE’s International Women in Pharma Steering Committee, I do so with immense gratitude.
This is my last column in Pharmaceutical Engineering®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.