– May/June 2008

Table of Contents


A Risk-Based Approach to Cleaning Validation using Visible Residue Limits
by Richard J. Forsyth and Jeffrey L. Hartman
This article describes the development of a Visible Residue Limits (VRL) program in a pharmaceutical manufacturing facility, including sample and viewing parameters. Opportunities for VRL implementation were identified in both pilot plant and manufacturing settings.
GAMP 5 Quality Risk Management Approach
by Kevin C. Martin and Dr. Arthur (Randy) Perez
This article describes how the GAMP 5 quality risk management strategy offers a pragmatic approach to computer systems compliance.

Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness by Christian Woelbeling and the Regional PAT COP from ISPE DACH Affiliate
This article summarizes the first four chapters of the PAT awareness document created by the PAT COP and explains how QbD/PAT management awareness can be created.
Industry Interview Series: Ruediger Dorn, Managing Director, Worldwide Pharmaceutical Industry, Microsoft
In this interview, Ruediger Dorn discusses Microsoft’s focus on the life sciences and the evolving relationship between plant operations and IT. Speaking from experience in auto manufacturing, he gives his thoughts on current challenges in the pharmaceutical industry.
Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES)
by Joseph F. deSpautz and Gregory Ruklic
This article summarizes the domain methodology described in the GAMP® Good Practice Guide on Manufacturing Execution Systems currently under development.
Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System
by Gamal Amer
This article identifies ways to mitigate the risk associated with the manufacture of drug products.
On-line Exclusive Articles

Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord and Michael Porter
This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans, ISPE Technical Documents Writer/Editor
Introduction to ICH: Essential Background to PQLI
by Dr. Kate E. McCormick, ISPE European Education Advisor
Global Regulatory News


Fast mirror: