GAMP Good Practice Guide: Testing GxP Systems (Second Edition)

GAMP Good Practice Guide: Testing GxP Systems (Second Edition) cover image

Title:

GAMP Good Practice Guide: Testing GxP Systems (Second Edition)

Author(s):

Ashley, Kevin; Ashworth, Karen; Buchanan, Roger; Davey, Jonathan; Dawson, Stephen; Heintzman, Angille K.; Mewborn, Daniel G.; Montgomery, Daniel; Ramesh, Radha; Sanders, Genni; Smerdon, George; Smith, Paul; Stanton, Kimberly; Stokes, David; Subramanian, Thanabalan; Theobald, Matthew; Tinson, Steve; Topham, Simon; Vidstrup, Anders; Waddick, Linda; Wakeham, Charlie

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Author(s): Ashley, Kevin; Ashworth, Karen; Buchanan, Roger; Davey, Jonathan; Dawson, Stephen; Heintzman, Angille K.; Mewborn, Daniel G.; Montgomery, Daniel; Ramesh, Radha; Sanders, Genni; Smerdon, George; Smith, Paul; Stanton, Kimberly; Stokes, David; Subramanian, Thanabalan; Theobald, Matthew; Tinson, Steve; Topham, Simon; Vidstrup, Anders; Waddick, Linda; Wakeham, Charlie

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.

Table of Contents

GAMP Good Practice Guide: Testing GxP Systems (Second Edition)

Full Title: ISPE GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
Pages: 276
Published: 2012-12-17

Table of Contents pages: 1 2

Table of Contents pages: 1 2