November/December 2014
Volume 34, Number 6

 

    Supply Chain Management

    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.
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    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.
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    Facilities and Equipment

    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.
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    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.
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    Production Systems

    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.
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    Regulatory Compliance

    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.
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    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.
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    Also Inside

    From the Editor
    by Gloria Hall, Editor, Pharmaceutical Engineering

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    From the PEC Chair
    by Roger Nosal, Chair, Pharmaceutical Engineering Committee

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    ISPE Update
    ISPE Trains MHRA; Three Impressive Keynotes Address ISPE Annual Meeting Delegates; 2014 Award Winners Recognized at ISPE Annual Meeting; ISPE Plan to Prevent Drug Shortages; ISPE Process Validation (PV) Team Provides Answers to Frequently Asked PV Lifecycle Approach Questions
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    Classified Advertising with Advertiser’s Index

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    Online Exclusives

    Global Regulatory News

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    Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework
    by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore, and Evdokia Korakianiti
    This article presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
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    Starting Materials Selection and Life Cycle Management
    by Richard Andrews, Mike James, Luc Janssens, Paul Marshall, Frank Montgomery, and Ron Ogilvie
    This article discusses the selection of Starting Materials (SMs) for the commercial manufacture of Active Pharmaceutical Ingredients (APIs) and challenges and potential solutions to the selection and agreement of SMs.
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    NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2014 ISPE. All rights reserved.)


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