September/October 2005
Volume 25, Number 5

Theme: Life Sciences

Table of Contents

Articles

Applying Six Sigma Principles to a Bulk and Fill/Finish Biopharmaceutical Process
by Bikash Chatterjee, Benir Ruano, and Kenneth Myers
This article discusses the methods and tools employed using Six Sigma to optimize a bulk biopharmaceutical process, providing an increase in overall plant capacity using a structured process improvement approach.
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Advanced Process Control Simplified by Matt Bothe,PE This article provides a definition of Advanced Process Control (APC), a viable implementation technique, introduction to associated tools, and statement with regard to sources of expertise. Download Article...

The Impact on Supply Logistics of Different Randomization and Medication Management Strategies Using Interactive Voice Response (IVR) Systems by Damian McEntegart and Barry O’Gorman This article explores the relationship between the chosen randomization methodology for a trial and the medication management techniques used when incorporating Interactive Voice Response technologies. Download Article...

Delivering Affordable Innovation: Opportunities in Pharmaceutical Manufacturing Processes and Facilities by Andrew A. Signore, PE This article describes how project managers can contribute to enhanced product delivery through improved manufacturing processes and facilities which deliver value-driven products with lower costs, better compliance, and lower risks. Download Article...

Position Paper: Use of Building Management Systems and Environmental Monitoring Systems in Regulated Environments by ISPE GAMP® Forum, Special Interest Group This article presents practical risk-based advice regarding the implementation and management of computerized aspecis of a Building Management System. Download Article...

Interview with Joe Morin, Vice President of Engineering, Human Genome Sciences, Inc. by Cathy Middelberg ISPE Tours Human Genome Sciences, Inc. Clinical Manufacturing Facility and Interviews Joe Morin, Vice President of Engineering. Download Article...

An Approach to IT Infrastructure Qualification by David Stephenson This article describes a method for the qualification of IT infrastructure that can be scaled down to fit multiple organizations, whether small or large. Download Article...

From World Class Research to World Class Manufacturing: The Challenges by Professor Roger S. Benson, FREng This article presents benchmark data for the pharmaceutical industry and analyzes the barriers and opportunities in moving from the existing to best in industry performance in research and operations. Download Article...

ISPE 25th Anniversary Feature by Don Cattaneo and Cheryl Cattaneo The Beginning of ISPE's 25 Years by Don Cattaneo, Retired, Drug & Device Associates, ISPE Past President and Founding Member, and Cheryl Cattaneo, ISPE Founding Staff Member Download Article...