Pharmaceutical Engineering is pleased to announce that the winner of the 2013 Roger F. Sherwood Article of the Year Award is:
January/February 2013, Volume 33, Number 1
Automating a Manual Cleaning Program in a Multi-Product Biopharmaceutical Manufacturing Operation ( 7 MB)
by Gordon Leichter, PhD and John Spohn, CPIP
This article discusses how to implement automatic washing in facilities where manual washing is conducted and provides valuable insight into lessons learned and key considerations in the planning for their future-state process.
Gordon Leichter, PhD
John Spohn, CPIP
The winner was recognized at ISPE’s 2013 Annual Meeting, 3-6 November in Washington D.C., USA, and selected from the following group of finalists:
Coding Solutions: An Essential Component for Serialization
by William P. Bonaccorsi
This article presents feedback from some of the leading healthcare companies regarding techniques and provides guidance for selecting proper coding.
Assured Construction Quality Saves Time and Money
by Jay Lad and Bruce Beck
This article demonstrates how Eli Lilly increased field efficiency and productivity, lowered costs, and improved overall build quality by implementing a proactive field quality assurance program and the latest technology.
Follow-on Biologics: Will the New Biologics Price Competition and innovation Act, Live Up to the Waxman-Hatch 1984 Expectations
by Michael R. Goodman
This opinion article presents a candid look at the motivations behind the new biosimilar legislation and if it really will be as influential as the Drug Price Competition and Patent Term Restoration Act of 1984.
Commissioning and Qualification (Verification) in the Pharmaceutical Product Process Lifecycle
by David Dolgin
This article discusses the role of Commissioning and Qualification as “Stage 2a” of the Process Validation Lifecycle described in the US FDA’s Guidance on Process Validation. It also explains how the concepts of Quality Risk Management and QbD are incorporated into facility and system verification efforts as detailed by two recently published ISPE Guides.
Compliant Cloud Computing – Managing the Risks
by David Stokes
This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information Technology (IT) outsourcing, and how the specific risks associated with cloud computing’s essential characteristics can be understood, assessed, and mitigated.