May/June 2007
Volume 27, Number 3
Theme: Commissioning and Qualification
Table of Contents
On-Line Exclusive Articles
A Multi-Functional Polymeric Nanoparticle Strategy for Modulation of Drug Resistance in Cancer
by Lilian E. van Vlerken and 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 GAMP Italia - Equipment Validation Workgroup: Sandro De Caris, Marco Bellentani, Beny Fricano, Carlo Bestetti, Marco Silvestri, and 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, and 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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Articles
Testing, Commissioning, Qualification, and Acceptance of Biopharmaceutical Skids
by Roy F. Greenwald and 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 and 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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