Article of the Year
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.
About the Roger F. Sherwood Article of the Year Award
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. The criteria for judging is as follows:
- Is it useful to the readers in their efforts to improve the industry and themselves?
- Does it increase knowledge or understanding of key topics?
- Is it clear and easy to read?
- Does it include high-quality artwork, graphs, and tables?
- Is it an appropriate length?
ISPE’s Article of the Year Award recognizes an outstanding author contribution to Pharmaceutical Engineering. Finalists are chosen from the September/October issue of the previous year through the July/August issue of the current year. Each is evaluated by a panel of volunteer reviewers a variety of criteria, including the importance and timeliness of the subject matter and the quality of the presentation.
2015 Article of the Year Finalists
A Framework for Implementing Stage 3 Continued Process Verification for Legacy Products
by Bikash Chatterjee and Wai Wong
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.
A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipients
by Sia Chong Hock, Sean Lee Ji Yang, Vimal Sachdeva, and Chan Lai Wah
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.
Risk Analysis and Annual Training Program Definition
by Luca Falce
This article presents an example of risk analysis.
The FDA Observation Response: Seven Common Mistakes
by Carol Brandt
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.
Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework (Part 1 of 2)
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.
Content Uniformity Discussions: Current USP Developments Regarding and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity
by James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani
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.