ISPE’s Roger F. Sherwood Article of the Year award was established in 1993 to increase article submissions and improve the quality of those received. In the early years, judges rated each issue's technical articles against a set of six criteria, then selected an annual winner.
Two decades later, while recognizing the merit of the original intent, the award has been refreshed to showcase the best content in Pharmaceutical Engineering® magazine, increase industry recognition, highlight ISPE’s reputation as a global knowledge leader, and bolster magazine content quality.
For 2017, a panel of judges was assembled, comprising two Board members, the Knowledge Network Council Chair, Pharmaceutical Engineering Committee Chair, Guidance Documents Committee Chair, one PEC member, two Young Professionals, and two senior ISPE staff members.
To be considered, each article was required to meet the following criteria:
After reviewing all articles published in 2017, the judges chose a unanimous winner:
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
The current submission-based control strategy plays a key role in ensuring that critical quality attributes are met, and the quality target product profile is realized. It does not, however, consider GMP, facilities, utilities, equipment and other production-specific controls to mitigate risk and ensure an effective, reliable, and stable production process. In addition, the effect of unknown process parameters, raw material attributes, and impurities usually are not sufficiently addressed in the control strategy lifecycle management—it is often impossible to predict such variations for a production lifecycle already in development
The ISPE Pharma 4.0 SIG team is proud to receive this award. This article is a great collaborative work, with contributions from SIG members; it reflects the start of a practical road map for applying digitalization and Industry 4.0 in the pharmaceutical industry. We look forward to developing the "holistic control strategy" concept, based on ICH standards, to bring digital maturity and data integrity by design into the pharmaceutical value network and enable flexible pharmaceutical manufacturing.2017 Article of the Year Award Authors