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A Risk-Based Approach to Testing of GxP Systems (Second Edition)

2016-12-07 by ISPE Korea

 

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.

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ISPE Baseline Guide: Oral Solid Dosage Forms (Third Edition)

A Risk-Based Approach to Compliant GxP Computerized Systems