Mitigate Risk, Facilitate Project Delivery, Integrate Sustainability, and Improve Maintainability for Advanced Technology Facilities by Allan Chasey, PhD, PE This article presents a project management vision that uses...

Accelerating the Fight Against Chickenpox and Shingles by Rochelle Runas This is a case study on Merck’s Vaccine Bulk Manufacturing Facility (VBF) Program of Projects, Overall Winner of the 2012 Facility of the Year...

Current Scientific Status and Regulatory Control of Traditional/Herbal Medicinal Products: Globalization Challenges by Dr. Chan Lai Wah, Sia Chong Hock, and Tan Kiat Yun This article presents an overview of the current...

The Increasing Trend of Adherence Packaging and the Implications to Manufacturing by John Musaus and Mel Bahr This article presents data that highlights the increasing market trend to use adherence packaging and...

Managing the Extended R&D Supply Chain by Petra Bielmeier and Geert Crauwels This article presents the R&D supply chain and manufacturing operations, from the manufacturing of Active Pharmaceutical Ingredients (APIs)...

ISPE’s President and CEO: Building Member Value with a Renewed Focus on Regulatory Affairs Nancy S. Berg reflects on her first 100 days as ISPE’s new leader and summarizes her plans to build Member value and reenergize...

New ISPE President and CEO Sets the Tone for ISPE's Work Ahead Nancy S. Berg took the helm of ISPE in January as the new President and CEO. In the few weeks since her arrival, she has been working to focus ISPE around...

Case Study: MedImmune’s Frederick Manufacturing Center (FMC) Expansion, Overall Winner, 2011 Facility of the Year Awards by Rochelle Runas This article presents the story of how MedImmune used ordinary tools in...

Applying Predictive Maintenance Techniques to Utility Systems by Padraig Liggan and David Lyons This article discusses how Predictive Maintenance (PdM) technologies can be successfully applied to both GMP and non-GMP...

Project Management Best Practices: Improving Schedule Using a Distributed Workforce by Mark Albano, Bruce Kane, and Robert Thomas This article presents more than a decade of project management learning about distributing...

Quality Risk Management (QRM) Tool Selection: Getting to Right First Time by Kristin S. Murray and Stephen Reich This article presents how the quality and utility of Quality Risk Management (QRM) may be highly influenced...

2011 Facility of the Year Awards Supplement by Rochelle Runas Labeling Pharma "Green" by Dana Buker and Jamie Kaushik This article presents arguments for the implementation of an electronic labeling system in the life...

Case Study: Genentech's ECP-1 Bacterial Manufacturing Facility, Overall Winner, 2010 Facility of the Year Awards by Rochelle Runas This article presents the story of how innovative project execution and strong teamwork...

The Challenges of Regulatory Change Management: Does ICH Quality Trio Provide the Solution? by Mary Oates, Michael Marini, and Barry McCloy It is hoped that this article will stimulate the necessary dialogue among...

Volume 30, Number 6 Table of Contents Articles Risk-Based MES Implementation Using Hazard Analysis and Critical Control Points (HACCP) by Tineke Bos, Paul Irving, and Philip Rees This article presents the benefits of...

Volume 30, Number 5 Table of Contents Articles Lean Maintenance – A Risk-Based Approach by Gerard Clarke, Gerry Mulryan, and Padraig Liggan This article presents an industry case study of the application of lean...

Volume 30, Number 4 Table of Contents Articles Quality by Design using an Integrated Active Pharmaceutical Ingredient – Drug Product Approach to Development by Vince McCurdy, Mary T. am Ende, Frank R. Busch, Jason...

Volume 30, Number 3 Table of Contents Articles Simple Strategies to Improve Bioprocess Pure Culture Processing by Michael Hines, Chris Holmes, and Ryan Schad This article presents strategies to improve bioreactions by...