November / December 2014

2014 Nov/Dec Issue Cover

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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 in the objective evaluation of alternative contract service providers.

Establishing and Managing Processes Enabling Delivery and Returns of Investigational Medicinal Products (IMPs) to Patient's Homes
by Massimo Eli, Catherine Hall, Marianne Oth, PhD, Adrian Peskett, and Esther Sadler-Williams
This article overviews the regulatory environment and the potential supply strategies for shipping clinical supplies Direct to Patient (DTP) homes.

Isolators Selection, Design, Decontamination, and Validation
by Nick Barbu and Robert Zwick
This article presents the selection, design, and validation of isolators to be used by the Musculoskeletal Transplant Foundation for the production of Demineralized Bone Matrix putty.

Ease Your Reshoring Transition with the Right Domestic Outsourcing Partner
by Mark Danna
This article presents an overview of current reshoring trend, some of the factors fueling that trend, and a discussion of how the challenges of reshoring can be ameliorated by teaming with a domestic outsource partner.

Application of Lean Six Sigma to Optimize a Legacy Cleaning Process
by Emmet Manning, Brian Earls, Keith Bader, Fearghal Downey, PhD, and Kelly Scalva
This article presents a successfully structured, data driven, cross-functional team approach for implementing an improved automated cleaning process, which reduced the overall duration for decontamination and cleaning.

A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipients
by Sia Chong Hock, Sean Lee Ji Yang, Vimal Sachdeva, and Chan Lai Wah
This article presents an overview of the regulations and international developments on quality and supply chain integrity of pharmaceutical excipients, analyzing the challenges faced by regulatory authorities with recommendations to improve the excipient control framework.

Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing
by Weibing Ding, Gary Madsen, Ekta Mahajan, Seamus O’Connor, and Ken Wong
This article presents a concensus standardized extractables testing protocol for single-use systems in biomanufacturing.