GAMP COP Articles

Pharmaceutical Engineering Articles

Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the subject matter of the GAMP COP.

The Return on Investment (ROI) of Test Automation ( 1 MB)
July/August 2012, 32(4)
by: by Stefan Münch, Peter Brandstetter, Konstantin Clevermann, Oliver Kieckhoefel, and Ernst Reiner Schäfer
*The spreadsheet ROI of Test Automation Calculator ( 71 KB) complements this article.
Using GAMP 5 for Rapid Deployment ( 2 MB)
March/April 2009, 29(2)
by: Markus Roemer, Hermann Schaefer
GAMP 5 – Enabling Innovation ( 227 KB)
January/February 2008, 28(1)
by: Sion Wyn
GAMP 5 Quality Risk Management Approach ( 439 KB)
May/June 2008, 28(3)
by: Kevin C. Martin, Arthur (Randy) Perez
GAMP® Traceability for GxP Regulated Applications ( 133 KB)
January/February 2006, 26(1)
Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes ( 334 KB)
May/June 2003, 23(3)
GAMP Life Cycle Documents as Effective Communication Tools ( 139 KB)
May/June 2003, 23(3)
by: Matt Bothe
Legacy Systems: GAMP Good Practice Guide: The Validation of Legacy Systems ( 298 KB)
November/December 2003, 23(6)