Volume 27, Number 3
On-Line Exclusive Articles
A Multi-Functional Polymeric Nanoparticle Strategy for Modulation of Drug Resistance in Cancer
by Lilian E. van Vlerken, Mansoor M. Amiji
This article describes an investigation on the use of a combination therapy administered within polymeric nanoparticles in order to overcome Multiple Drug Resistance (MDR), one of the most challenging threats to survival in the battle against cancer.
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Risk-Based Equipment Qualification: A User/Supplier Cooperative Approach
by Marco Bellentani, Beny Fricano, Carlo Bestetti, Marco Silvestri, Barbara Testoni
This article presents an efficient cooperative approach to Commissioning and Qualification (C&Q) for manufacturing equipment and covers the entire life cycle for the specification, design, manufacture, installation, commissioning, qualification, operation, and maintenance of the equipment in a risk- based approach. This article reflects the current status of the work in progress conducted by the GAMP Italia Equipment Validation Workgroup.
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Variable Frequency Drives Role in Control System Strategy
by Irina Kurjatko
This article gives an overview of Variable Frequency Drive (VFD) technology and its various applications to a control system strategy.
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Effective Commissioning Strategy
by Chris Ward, Stephen Anisko, Jenny Oberlag, Matthew B. Davis
This article examines a combined commissioning and qualification approach and provides some general definitions of the commissioning and qualification process.
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by Roy F. Greenwald, Thys Smit
This article describes the tremendous variability in requirements for testing and final acceptance of process skids and suggests specific steps to standardize that process.
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A Risk-Based Approach to Packaging Machinery Validation
by Jonathan Davey
This article describes a method of validating both the hardware and the software in conversion and packaging machinery, using a risk-based approach.
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Integration of Commissioning and Qualification (C&Q) with Other Phases of the Project Lifecycle
by John Devlin
This article considers the integration of the C&Q process with engineering, procurement, construction, as well as other sustaining operations activities, including production, quality, and maintenance.
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Using AIMS Tools to Automate the Qualification and Validation Lifecycle
by Fursey Duggan, Nick Giuffrida
This article presents a number of examples of software tools which provide an integrated approach to qualification and the validation lifecycle.
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Industry Interview Series: Frederick Sexton, Senior Vice President, Technical Operations, Purdue Pharma
A key member of ISPE's International Leadership Forum discusses why Purdue is focusing on expanding its product portfolio through internal development and licensing; how cost pressures can be a driver for innovation in R&D, as well as manufacturing; the importance of forging strategic alliances; and the extreme measures the company is taking to prevent counterfeiting.
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Containment Considerations for Toxic and Potent Aseptic Liquid Filling
by Lee Francis
This article presents containment requirements for liquid handling operations.
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Global Regulatory News
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