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Table of Contents

Articles

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

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