Volume 25, Number 5

Table of Contents

Articles

Applying Six Sigma Principles to a Bulk and Fill/Finish Biopharmaceutical Process

by Bikash Chatterjee, Benir Ruano, 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.

Advanced Process Control Simplified

by Matt Bothe
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

The Impact on Supply Logistics of Different Randomization and Medication Management Strategies Using Interactive Voice Response (IVR) Systems

by Damian McEntegart, Barry O
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.

Delivering Affordable Innovation: Opportunities in Pharmaceutical Manufacturing Processes and Facilities

by Andrew A. Signore
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.

Position Paper: Use of Building Management Systems and Environmental Monitoring Systems in Regulated Environments

by Special Interest Group
This article presents practical risk-based advice regarding the implementation and management of computerized aspecis of a Building Management System.

Interview with Joe Morin

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

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.

From World Class Research to World Class Manufacturing: The Challenges

by Professor Roger S. Benson
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.

ISPE 25th Anniversary Feature

by Don Cattaneo, 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

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