March/April 2014
Volume 34, Number 2


    Quality Systems

    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.
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    Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
    by Anil K. Rattan, PhD and Michael Rubacha
    This article presents a consistent, compliant and practical risk-based validation process for laboratory systems.
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    Product Development

    Current Events in Blend and Content Uniformity
    by James S. Bergum, PhD, James K. Prescott, Ravindra W. Tejwani, Thomas P. Garcia, PhD, Jon Clark, and William Brown
    This article presents a summary of the stratified sampling session held at the 2013 ISPE Annual Meeting.
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    Facilities and Equipment

    Project Execution Planning: The Key to Successful Pharmaceutical Project Delivery
    by Robert Garner
    This article presents the importance of a Project Execution Plan (PEP) for a pharmaceutical facilities project, outlines the fundamental aspects of a PEP, and details what should be included in each section.
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    Construction Practices: Contamination Risk Reduction within Ongoing Operations
    by Charles Hammond and Steve W. Van Wormer
    This article presents good construction practices for work in existing pharmaceutical facilities and encourages further development of construction procedures to prevent product safety issues.
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    High Purity Process Piping: Harmonization of ASME Codes and Standards
    by Barbara Henon, Vince Molina, Richard Campbell, and William Huitt
    This article presents interactions between the ASME Bioprocessing Equipment (BPE) Standard and ASME B31.3 Process Piping Code Committees following the addition of Chapter X High Purity Piping to the 2010 Edition of B31.3. This collaboration of ASME Committees will help to assure both safety and cleanability of high purity piping systems.
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    The Dirt on Cleaning and Sanitization
    by Neil Lewis and Steve Shank
    This article presents an overview of the basic concepts and principles of clean design which should be applied when considering equipment and system design.
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    On-Line TOC Monitoring in GMP Parts Washers
    by Marcel Dion, Olivier Van Houtte, and George Verghese
    This article presents a TOC monitoring system integrated into a parts washer and discusses how it can increase productivity, help meet PAT and QbD goals, and provide ongoing assurance over the life cycle of the process.
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    President's Message

    Spanning the Globe and Making a Difference
    by Nancy Berg, ISPE President/CEO
    Berg discusses how ISPE is stimulating new approaches, leading change in how business is conducted and influencing how regulations are being developed through global regulatory interaction.
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    Also Inside

    From the Editor
    by Gloria Hall, Editor, Pharmaceutical Engineering

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    ISPE Update
    New Quality Culture Drives the Comeback of Pharmaceutical Engineering; Health and Human Services Releases its Semiannual Regulatory Agenda; Janet Woodcock Includes ISPE in FDA Statement to Congress; Background of Quality Metrics; Excitement Builds for 2014 Facility of the Year Awards; Japan Affiliate “On the Road” Again
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    Classified Advertising with Advertiser’s Index

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    Online Exclusives

    Global Regulatory News

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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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