ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) [German Translation]
Published:July 2013
Pages:284
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.
- Kevin Ashley, Siemens Healthcare Diagnostics, United Kingdom
- Karen Ashworth (Co-Lead), Karen Ashworth Consulting, United Kingdom
- Roger Buchanan, Lilly UK, United Kingdom
- Jonathan Davey, Provalidus Ltd., United Kingdom
- Stephen Dawson, Eden Biodesign Ltd., United Kingdom
- Angille K. Heintzman, NHS Blood and Transplant, United Kingdom
- Daniel G. Mewborn, Eli Lilly and Company, USA
- Daniel Montgomery, Covance, Inc., USA
- Radha Ramesh, TCS, USA
- Genni Sanders, Systematicity, United Kingdom
- George Smerdon, Industrial Technology Systems Ltd. (ITS), United Kingdom
- Paul Smith, Agilent Technologies, United Kingdom
- Kimberly Stanton, QPharma, Inc., USA
- David Stokes, Business & Decision Life Sciences, United Kingdom
- Thanabalan Subramanian, GE Healthcare, United Kingdom
- Matthew Theobald, Three Circles, United Kingdom
- Steve Tinson, Scitech, United Kingdom
- Simon Topham, Napp Pharmaceuticals Limited, United Kingdom
- Anders Vidstrup, NNIT A/S, Denmark
- Linda Waddick, Eli Lilly and Company, USA
- Charlie Wakeham (Co-Lead), Pall Life Sciences, United Kingdom
This document, the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems, represents a revision of the first edition, ISPE GAMP® GPG – Testing and is intended as a supplement to ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. This Guide focuses on functional, structural, and performance testing. It has been updated to align with the concepts and terminology of GAMP® 5 and regulatory and industry developments which focus attention on patient safety, product quality, and data integrity.
The ISPE GAMP® Community of Practice Document Task Team was asked to revise this Guide. The team consisted of representatives from regulated organizations, contract research organizations, suppliers of pharmaceutical systems and equipment, and consultants.