ISPE Pharmaceutical Engineering Magazine

Pairing Knowledge with Imagination

Highlights from the May/June issue of Pharmaceutical Engineering® magazine from Editor in Chief, Anna Maria di Giorgio.

Imagination is more important than knowledge.
Knowledge is limited. Imagination encircles the world.
— Albert Einstein1


Albert Einstein’s statement captures the innovative spirit that underlies the drive of the 2017 recipients of ISPE’s Facility of the Year Awards (FOYA) Program, now in its fourteenth year. The annual program represents the heartbeat of our association, and the breath of its members.

This year’s category winners and honorable mentions, highlighted in the Special Supplement—2017 Facility of the Year Awards, have demonstrated their skill at pairing knowledge with imagination to achieve manufacturing excellence.  They were honored at the FOYA Banquet, held during the ISPE/FDA/PQRI Quality Manufacturing Conference, 5–7 June 2017 in Bethesda, Maryland, US. (If you were unable to attend, join us at the ISPE 2017 Annual Meeting & Expo, 29 October-1 November 2017 in San Diego, California when we will unveil the 2017 FOYA Overall Winner.)

Greater Than the Sum of Its Parts

You can’t really talk about manufacturing without invoking quality—that elusive attribute, equal parts quantitative and qualitative—whose whole is infinitely greater than the sum of its parts. It is both a goal and a fundamental characteristic of the medicines and devices we manufacture. Quality manufacturing will keep drug shortages at bay and produce safe, effective medicines that are available to those who need them, wherever they are located. To achieve these lofty goals, industry must embrace a quality culture mindset, and adopt the tools needed to instill that mindset in employees and suppliers.

Inspiration, Innovation, Intelligence

In the May/June issue of Pharmaceutical Engineering® magazine, ISPE’s Chair Mike Arnold looks at Industry 4.0 and what it augurs for manufacturing. In his editorial, What Is “Industry 4.0” and Are We Ready For It?, he likens the next wave of changes to the mobile revolution of the 1990s, and draws parallels with our collective effort to make drugs more accessible and affordable to patients.

Our Special Report: Continuous Manufacturing looks at continuous manufacturing from the perspective of the organizers and key presenters of ISPE’s first Continuous Manufacturing conference. While both industry and regulators recognize that continuous manufacturing offers significant quality and cost advantages, barriers and challenges to adoption and implementation remain. This report discusses findings, outcomes, and the regulatory Q&A session from the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland.

ISPE Pharmaceutical Engineering Magazine 2017 May/June IssueAnd our cover story, A Matter of Well-Being, pays tribute to an engineer’s engineer, who believed in the power of his vision not just for himself, but for the pharmaceutical industry as well. Recently retired Pfizer Executive Vice President Anthony Maddaluna sat down with Pharmaceutical Engineering to discuss his 42 years in the industry, his passion for excellence, and the complexities of supply chain organizational structure.

Among our technical articles in this issue, Facilities and Equipment: Corrosion Investigation of Pharmaceutical Clean Steam Systems is a must-read. Corrosion byproducts encountered in clean and pure steam systems are present to some degree in every system, but many lack routine inspection and maintenance that could control corrosion and particulate migration from oxide deposit exfoliation. Drew Coleman and Daryl Roll report on four case studies that tested condensate for metals and particles, and conducted a risk assessment of potential corrosion effects on process and critical utility systems.

Equally compelling is the article A Holistic Approach to Production Control—From Industry 4.0 to Pharma 4.0 by Prof. Dr. Christoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD, in which they present the work of the newly formed ISPE Holistic Production Control Strategy Group. The group has identified and summarized the need for a redefined methodology for control strategy implementation, which could incorporate ICH concepts, embrace digitalization and big data management, and include all activities throughout the supply chain and the product lifecycle.

Count on ISPE

We can’t manufacture imagination. Excellence, on the other hand, we can: by training our students and Young Professionals to value it, our middle managers to foster it, and our executives to recognize and reward it. By embracing change and planning for it.  It won’t be long before Industry 4.0 has reached beyond manufacturing to change the way patients access and use drugs, or for the pharmaceutical manufacturing industry to reimagine what it means to manufacture drugs and medical devices. And for the drugs themselves to be reinvented by the biopharmaceutical sector.

Industry professionals around the world are conceiving a new architecture of drug manufacturing. We at ISPE are here to support, reward, and recognize it.

Happy reading.

Anna Maria di Giorgio
Editor in chief

Stay up-to-date on what is going in the pharmaceutical industry by reading Pharmaceutical Engineering® magazine.  Get Pharmaceutical Engineering magazine bi-monthly with your ISPE membership.  Membership benefits include deep discounts on guidance documents, receive expert feedback in the Communities of Practice, discounts on conferences and training, opportunity to review and comment on regulatory guidance’s and more!  Join today!

1. Viereck, George Sylvester “What Life Means to Einstein.” Saturday Evening Post, 26 October 1929, p. 117.