September/October 2012
Volume 32, Number 5

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 © 2012 ISPE. All rights reserved.)



The Increasing Trend of Adherence Packaging and the Implications to Manufacturing
by John Musaus and Mel Bahr
This article presents data that highlights the increasing market trend to use adherence packaging and highlights the design and manufacturing options that should be considered to adopt this strategy.
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Serialization – A Worldwide Challenge
by Dana Buker and David Loy
This article presents operational considerations and related recommended approaches for implementing serialization to address existing and upcoming regulatory requirements in a pharmaceutical environment.
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Pharmaceutical Packaging with Brite Stock Manufacturing
by Mel Bahr
This article presents a marketing strategy that is implemented using existing or new primary and secondary packaging systems.
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Coding Solutions: An Essential Component for Serialization
by William P. Bonaccorsi
This article presents feedback from some of the leading healthcare companies regarding techniques and provides guidance for selecting proper coding.
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Calcium Alginate Microparticles As a Non-Condensing DNA Delivery and Transfection System for Macrophages
by Mansoor Amiji, PhD and Shardool Jain
This article was developed from the presentation by a finalist in the ISPE 2011 International Student Poster Competition.
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Traditional Lot Traceability Approaches Are Not Sufficient to Enable Upstream/Downstream Correlation Analysis for Quality by Design (QbD)
by Victor Shashilov, PhD and Justin Neway, PhD
This article is based on a webcast presented by the authors in cooperation with ISPE.
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Bringing New Products to Market Faster
by Adam Fermier, Paul McKenzie, Terry Murphy, Leif Poulsen, and Gene Schaefer
This article presents ideas, concepts, and prototype experience on how to bring products faster to market through a more structured and integrated management of product, process, and analytical data based on proven industrial standards (S88/S95) and data warehouse technology.
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Results and Analysis of the ISPE Survey Regarding Use of Non IMPs in Global Clinical Trials
by Lee Miller and Karen Main on behalf of the IP COP Non IMP Task Team
This article presents and analyzes the results of a survey regarding the use of Non Investigational Medicinal Products (NIMPs).
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Message from the President

  • Come and Experience the New ISPE

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Global Regulatory News

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ISPE Update

  • New Guide Provides Holistic View of Ozone Sanitization Systems
  • New Guide Establishes Industry Baseline for Quality Laboratory Facilities Design
  • The State of Quality by Design for Generics
  • ISPE’s PQLI Addresses Process Validation Topics
  • Pharmaceutical Engineering Announces Finalists of the Article of the Year Award
  • 2012 ISPE-CCPIE China Conference
  • 2012 ISPE Annual Meeting: Global GMP Solutions through Innovation and Transformation
  • ISPE Releases New Guidance for Designing and Constructing Packaging, Labeling, and Warehousing Facilities

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Classified Advertising with Advertiser’s Index

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Online Exclusive Articles

Resource Scheduling in QC Laboratories
by Rafi Maslaton
This article presents the various aspects of scheduling in QC laboratories.
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The State of Quality by Design for Generics
by Chris Potter, ISPE PQLI Technical Project Manager, and CMC Pharmaceutical Consultant
This article is a report on the joint ISPE - European Generics Association Meeting on applying QbD to development and manufacture of generic medicines.
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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 © 2012 ISPE. All rights reserved.)