Volume 23, Number 6

Table of Contents

Articles

An Integrated Approach to Design

by Jerold W. Boddy, Kevin Scannell
This article addresses opportunities to find efficiencies and savings along the spectrum of critical services that includes design, commissioning, and validation.

The Road to Cleanroom Compliance

by Bob Cates, Larry DeShane
This article discusses how to operate and maintain an effective cleanroom program to meet pharmaceutical industry compliance regulations.

Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes Part 2 - Risk to Records

This article demonstrates how the risk analysis guidance in GAMP 4 can be applied to GMPs and Good Distribution Practices (GDPs).

Recommendations for Implementing a Calibration Program

by Yefim S. Gudesblat
This article presents the infrastructure of a GMP compliant Calibration Program based on technical and metrology methods.

Legacy Systems: GAMP Good Practice Guide: The Validation of Legacy Systems

This Guide discusses the considerations which should explain this activity and suggests a process to be followed in order to assess and validate Legacy Systems.

Evaluating Current Trends and Technology for Laboratory and Developmental Facilities What’s Right for Your Project?

by Bob McCleskey
This article presents current trends and technology in laboratory and development facility projects.

New Laboratory Design Helps Speed Up Research

by David Withee
This article describes a new, costeffective design method for increasing productivity in new or renovated laboratories.

Country Profile: Australia - Nov/Dec 2003

This section takes a look at the pharmaceutical industry in Australia; produced in collaboration with ISPE Australia.

Calibration Management - A European Perspective

by Brendan Barry, Nigel de Haas
This article presents the issues that need to be addressed when developing and operating aCalibration Management Program with emphasis on European regulations.

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