The winner was recognized at ISPE’s 2014 Annual Meeting in Las Vegas, Nevada, USA, and selected from the following group of finalists:
A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients
By Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva, and Chan Lai Wah, September/October 2013
This article presents an overview of the current regulations and developments in good manufacturing practices and supply chain integrity of active pharmaceutical ingredients, and analyzes the challenges faced by regulatory authorities and industry.
Steam Sterilization Principles
By Marcel Dion and Wayne Parker, November/December 2013
This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves.
Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
By Catherine E. Anderson and Brian J. Lloyd, PhD, January/February 2014
This article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment.
Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
By Anil K. Rattan, PhD and Michael Rubacha, March/April 2014
This article presents a consistent, compliant and practical risk-based validation process for laboratory systems.
A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description
By Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito, Bruce Guenter, and Patricia Thomas, May/June 2014
This article discusses the shipment of room temperature products from several perspectives: the changing regulatory environment, risk assessment and mitigation, new technologies and budgetary pressures.
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.
Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the 365 days.
Our team at Women in Pharma® has sat down and put together a...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" (HPW) could be found in the Ph. Eur. but will be removed in...