GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

Print this page         

Testing of GxP Systems cover thumbnail

Published: December 2012
276 Pages
Table of Contents ( 251 KB)

Formats Member Price Nonmember Price  
Bound Version $145 / €140 $455 / €400 buy now
Individual Download $145 / €140 $455 / €400 buy now

This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide has been recently expanded and updated to conform to GAMP® 5 standards and terminology and reflects ICH Q8, Q9, and Q10, Quality by Design and Process Analytical Technology principles. The updated Guide contains new information on cloud computing, automated testing and non-linear development and focuses on risk-based approaches that help suppliers to optimize their products and end-users to focus on critical areas.


GAMP® Gute-Praxis-Leitfaden: Ein risikobasierter Ansatz zum Test von GxP-Systemen (Zweite Auflage)

Inhaltsverzeichnis ( 760 KB)

Formats Member Price Nonmember Price  
Individual Download $145 / €115 $435 / €355 buy now


  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile



Know Before You Go: Process Validation Conferences
Friday, 21 Oct 2016 12.10

Chairman’s Chatter: Collaboration
Thursday, 20 Oct 2016 14.10

Moving to Single-Use Continuous Manufacturing
Wednesday, 19 Oct 2016 12.10