January/February 2012
Volume 32, Number 1



    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 extraordinary ways to build the MedImmune Frederick Manufacturing Center Expansion, Overall Winner of the 2011 Facility of the Year Awards.
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    Alternative Software Development Models and Methods in GxP Environments
    by Members of the ISPE GAMP D-A-C-H SIG ASDMM
    This article presents methods used for the development of all types of software, from infrastructure software to bespoke applications.
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    Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management
    by Alex Brindle, Steve Davy, David Tiffany, and Chris Watts
    This article presents a new type of risk tool. Risk Analysis and Mitigation Matrix (RAMM) was developed to be incorporated into a modern risk management system and align with latest FDA guidances.
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    Reducing Variability and Out-of-Specification Results by Implementing High Quality Gravimetric Sample Preparation (GSP)
    by Klaus Fritsch, Joanne Ratcliff, and Charles Ray
    This article presents the current limitations of outdated sample preparation workflows in analytical R&D and QA/QC laboratories and introduces new approaches to improving quality and reducing variability, errors, and Out-of-Specification (OOS) results.
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    A Quality Risk Management Approach to Review and Monitor Cleaning Processes
    by Ian Campbell and Dominic Thibeault
    This article presents a risk-based approach to continuous quality verification of cleaning procedures.
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    Industry Interview Series: Mary Oates, Vice President of Global Quality Operations, Pfizer
    by Cathy Middelberg and Jeff Hargroves
    Pfizer’s Vice President of Global Quality Operations discusses the elements and challenges of quality risk management. She provides insight into how Pfizer applies risk management to product quality decisions.
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    ISPE Update
    - ISPE Announces 2011 Award Winners at Global Annual Meeting - Ground-Breaking Guide Paves Way for Industry Standard on Interactive Response Technology - New Guide Addresses Unique Aspects of Project Management in Highly Regulated Pharmaceutical Industry - New Guide Bridges Gap between Baseline® Guide and Full ICH Q8, Q9, and Q10 Adaptation - New Good Practice Guides Focus on Quality by Design Principles and Practices - Updated Water and Steam Guide Addresses Decade of Changes in Regulations and Industry Practices
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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Administration of Quality Standards and Registration of Pharmaceutical Excipients in China
    by Ling Su, Jingyi Leung, and Phoon Bee Lim
    This article presents the definition of pharmaceutical excipients, pharmaceutical excipient standard and categories, pharmaceutical excipient submission requirements, and imported pharmaceutical excipient registration procedures in China.
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    Applying Fault Tree Analysis (FTA) as a Top Level Risk Management Tool in Software Development
    by Paul Noble, PhD
    This article presents the case that fault tree analysis is the better risk analysis method to apply early in software development projects.
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    A Risk Assessment Approach to Planning an API Production Facility
    by Kazuo Tozaki
    This article presents a new risk assessment table and discusses associated issues, including the targets of assessment, criticality, contents of the risk factors, and severity.
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    Control Strategy as the Keystone of the Product Lifecycle, from Product/Process Understanding to Continuous Process Verification and Improvement
    by Johanne Piriou, Bernard Elissondo, Michel Hertschuh and Roland Ollivier
    This article presents the general principles of Control Strategy (CS) and its evolution. A method for designing a CS and its filing in Common Technical Document (CTD) format are proposed. CS within the continuous process verification and product lifecycle is discussed.
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    Resource Planning in QC Laboratories
    by Rafi Maslaton
    This article presents a methodology and approach to resource planning, including both analysts and instruments in QC laboratories.
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    Global Regulatory News

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    Facility of the Future
    by Active Pharmaceutical Ingredients Community of Practice (API COP)
    This article presents a perspective on what the Facility of the Future will look like as envisioned by ISPE’s API community. The concepts in the article will form the basis of a series of planned ISPE Guidance Documents.
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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 © 2011 ISPE. All rights reserved.)

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