Drug Shortages and the Quality Debate by Carol Winfield and John Berridge Guest Editorial: Metrics that Give Voice to Quality by Joseph Famulare Conference Attracts 250 Enthusiastic Participants from Across Industry From...

Risk Assessment: Issues and Challenges by Joe Brady, PhD This article presents an opinion and a perspective on the practical application of risk assessment, on how to adopt a scientific approach to the risk management...

Facilities and Equipment Communication and Collaboration – Leadership Essentials in Pharmaceutical Project Management by Alandra Strain This article focuses on communication and collaboration as essential leadership...

Case Study: Applying a Risk-Based Decision Making Framework for Outsourcing by Bikash Chatterjee This article will discuss the application of Analytic Hierarchy Process (AHP) and Pairwise Comparison as a tool to assist...

Symposium Summary Report: The Use of Process Capability to Ensure Pharmaceutical Product Quality by Daniel Y. Peng, Richard Lostritto, Dafni Bika, Jean-Marie Geoffroy, Thomas Shepard, Brian Eden, Kenneth Coté, Alpesh...

Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination by Nissan Cohen and Shlomo Sackstein This article identifies the issues plaguing water systems with...

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...

A Practical Approach to Managing Knowledge - A Case Study of the Evolution of Knowledge Management (KM) at Merck The Know-Houw and Know-Why: An Interview with Merck Implementing a Successful Knowledge Management Program...

Moving from Quality Control to Quality Assurance by Guy Wingate, PhD This article provides ways to implement an effective quality management system to allow manufacturers to meet their ethical and regulatory obligations...

Application of Single-Use Equipment for Buffer Storage and Distribution in Medium Size mAb Production Facility by Wilfried Kappel, Bhimasen Vadavi, Sanjay Lodha, and Daniel Karrer, PhD This article presents a hybrid...

Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents by Andrew Walsh, MS, Mohammad Ovais, MP, Thomas Altmann, Gr FC, and Edward V. Sargent, PhD This article presents currently suggested...

Labeling Pharma “Green” and Compliant in a Track and Trace World by Dana Buker, David Loy, and Harini Pillalamarri This update presents a discussion of the current regulatory landscape and how compliance and a “green”...

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...

Establishing and Managing a Vendor Network for Clinical Supply Manufacturing Services by Francis Dumont and Sandra Onorato This article presents some essential operational and evaluation aspects of the Request for...

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...