Online Exclusive Articles

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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Resource Scheduling in QC Laboratories
by Rafi Maslaton

This article presents the various aspects of scheduling in QC laboratories.
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Bringing New Products to Market Faster
by Adam Fermier, Paul McKenzie, Terry Murphy, Leif Poulsen, and Gene Schaefer
July/August 2012
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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Administration of Quality Standards and Registration of Pharmaceutical Excipients in China
by Ling Su, Jingyi Leung, and Phoon Bee Lim
January/February 2012
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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Facility of the Future
by Active Pharmaceutical Ingredients Community of Practice (API COP)
January/February 2012
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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Resource Planning in QC Laboratories
by Rafi Maslaton
January/February 2012
This article presents a methodology and approach to resource planning, including both analysts and instruments in QC laboratories.
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Applying Fault Tree Analysis (FTA) as a Top Level Risk Management Tool in Software Development
by Paul Noble, PhD
January/February 2012
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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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
January/February 2012
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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Global Regulatory News

January/February 2012

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A Risk Assessment Approach to Planning an API Production Facility
by Kazuo Tozaki
January/February 2012
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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