Guest Editorial: by John E. Bournas, President and CEO, ISPE
by Jeff Odum, CPIP. This article will identify many key design issues of an SUS and provide experienced-based guidance on how to address them.
by Thomas Blitz, Ernst Felber, Robert Haas, Birgit Lorsbach, Andreas Marjoram, Roland Merkofer, Tobias Mueller, Nathalie Schuleit, Marc Vernier and Thomas Wellauer
Part 2 of this article describes tests and practical experiences in rouging formation and the influence of rouge coatings on cleaning efficiency.
by Daniel Y. Peng, Robert Lionberger, Alex Viehmann, Karthik Iyer and Lawrence X. Yu
This article presents the discussion on the use of control charts to evaluate pharmaceutical process variability.
by Katherine A. Bakeev
This article presents the discussion on minimizing risks in quality of pharmaceutical manufacturing using Raman spectroscopy, which provides a rapid, reliable means of testing in many different environments in manufacturing, including the loading dock.
by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti
This article is the first of a two-part series and presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
by Peter J. Marshall, Justin Mason-Home, John P. Farris, Erica L. Dahl and Fredrik Waern
This article reviews the significance related to high toxicity, and the complexity in determination of (bio) chemical exposure hazards and risks associated with ADC-related activities at all scales. High level approaches to mitigate and control these risks are proposed for consideration with the objective of establishing safe working environments and practices in a systematic, scientific manner, avoiding emotional or poorly informed responses which may, at the extremes, either create untenable risks of exposure or an overreaction to the extreme toxicity of the materials involved.