January/February 2011
Volume 31, Number 1



    The Challenges of Regulatory Change Management: Does ICH Quality Trio Provide the Solution?
    by Mary Oates, Michael Marini, and Barry McCloy
    It is hoped that this article will stimulate the necessary dialogue among industry and regulators to establish the baseline criteria to achieve a system in which the majority of changes can be made globally under the robust quality systems of a firm with total visibility to the health authorities upon request.
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    Continuous Verification – Providing an Alternative Approach to Process Validation
    by Richard Kettlewell, John Upfield, Rosemary Leak, and Andrew Harris
    This article presents an innovative approach to the completion of Performance Qualification (PQ).
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    Risk Management – A Key Requirement for Project Success
    by Brett Schroeder, John Alkemade, and Gordon Lawrence
    This article discusses how risk management can aid in project success. It looks at the potential gain from good risk management, examines some typical risks that recur regularly on projects, and offers a suggested methodology for managing project risks.
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    Risk-MaPP, ICH Q9, ASTM 2500 in Action: Project Advantages of Practical Quality Risk Management Approaches
    by Brian Andreasen, Jürgen Blasi, Holger Fabritz, Henrik Feldthusen, Niels Guldager, and Gert Moelgaard
    This article presents four case studies illustrating a wide range of applications for risk-based approaches in pharmaceutical engineering projects.
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    A Quantitative Study in Cross Contamination
    by Julian Wilkins
    This article is based on data acquired during an evaluation of the quantifiable risk of cross contamination in an Oral Solid Dosage (OSD) facility. This article is intended to provide some quantitative data to an area in which perception and not reality is the norm. There is really no published data on cross contamination.
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    Risk Assessment on Capital Equipment Planning for the Biotech and Pharmaceutical Market
    by Mark Mathis
    This article presents processes and metrics for identifying and evaluating risks associated with capital equipment planning during the Conceptual Project Planning Phase.
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    ISPE Update
    - Update on ISPE’s PQLI Program - The New and Improved Pre-Approval Inspections Program - 10th Anniversary of Japan Affiliate - Becoming a CPIP™
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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Global Regulatory News

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    ISPE Update – Additional Information on The New and Improved Pre-Approval Inspections Program
    by Rochelle Runas, ISPE Technical Writer
    - Investigator’s Perspective of the New PAI Compliance Program - Reviewers on Inspection – An ONDQA Perspective - An Industry Perspective on a Joint Inspection - Q&A with FDA
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    Business Process Management (BPM) Based Pharmaceutical Quality Management Systems: A Win-Win Between Compliance and Competitiveness
    by François Versini
    This article shows how a BPM-based Quality Management System optimizes the way to comply with today’s evolving processes and stay competitive in the marketplace.
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    Achieving a Validated Facility from a Set of Critical Quality Attributes
    by Magnus Jahnsson, Firas Al-Saffar, and Anna Kälvemark
    This article presents a risk-based work flow for design and validation of facilities, turning a set of Critical Quality Attributes into a validated facility. The main objectives are to improve quality assurance and traceability while saving cost and time.
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    Case Study: Application of the ISPE Baseline Guide for C&Q Yields Cost, Quality, and Budget Control
    by Robert A. Young and Humberto Rosas
    This case study provides an example of the positive results that can be obtained by the following principles set forth in the ISPE Baseline Guide® for Commissioning and Qualification, Volume 5.
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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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