Volume 27, Number 3

Table of Contents

Articles

Testing

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.

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.

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.

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.

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.

Containment Considerations for Toxic and Potent Aseptic Liquid Filling

by Lee Francis
This article presents containment requirements for liquid handling operations.

Departments

ISPE Update

Global Regulatory News

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