Congratulations to Luca Falce, 2015 winner, for his article “Risk Analysis and Annual Training Program Definition,” Pharmaceutical Engineering 35, no. 1 (January/February 2015): 44–52.
by Bikash Chatterjee and Wai Wong, September/October 2014.
This article presents a method to account for missing information and provides recommendations to understand a legacy product and how to apply the three stages of the new guidance to satisfy the FDA and other regulatory agencies.
by Sia Chong Hock, Sean Lee Ji Yang, Vimal Sachdeva, and Chan Lai Wah, November/December 2014.
This article presents an overview of the regulations and international developments on quality and supply chain integrity of pharmaceutical excipients, analyzing the challenges faced by regulatory authorities with recommendations to improve the excipient control framework.
by Luca Falce, January/February 2015.
This article presents an example of risk analysis.
by Carol Brandt, March/April 2015.
Seven common mistakes are identified when responding to FDA inspection observations. This article presents examples of regulated-industry responses that may not meet the FDA requirements for a thorough response.
by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti, May/June 2015.
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 James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani, July/August 2015.
Compare the performance of two statistical approaches (tolerance interval and ASTM E2709/E2810) to assess dosage unit uniformity. The potential impact that the approaches can have on the USP monograph is also discussed.
Pharmaceutical Engineering has established an "Article of the Year" award to recognize the contribution of authors. Articles are evaluated by a panel of volunteer reviewers according to a number of criteria, concentrating on the importance and timeliness of the subject matter and the quality of the presentation.