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ISPE Updates and Expands Guidance for Testing of GxP Systems

Ensure sufficient test coverage starting with a correct scope of testing

Published: Monday, January 21, 2013 - 11:09

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a leading authority on best practices for the pharmaceutical industry,  has issued updated and expanded guidance to help pharmaceutical companies maximize testing efficiency of computerized and software-based systems that affect patient safety, product quality, and data integrity. The second edition of the GAMP testing guide for GxP systems has been revised to conform with GAMP 5 concepts and terminology and reflect ICH Q8, Q9, and Q10, quality by design, and process analytical technology principles. It has also been expanded to include information on cloud computing, automated testing, and nonlinear development.

“We have aimed this guide at anyone who has ever worried that their testing is not sufficiently focused on the real risks to patient safety or wondered whether they might be doing too much or too little testing,” says Karen Ashworth, who co-led the industry group responsible for producing the guidance. “The guide offers practical advice on how to use risk assessment to define the correct scope of testing and on how to avoid costly duplication of testing that has already been done by a supplier or at an earlier phase of the system life cycle.”

The ISPE GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) encourages regulated pharmaceutical companies and their suppliers to work together to ensure sufficient test coverage to prove that systems are fit for their intended use and minimize duplicated effort. The guide provides answers as to which system elements should be tested, why they should be tested, how much testing is necessary, and how tests should be conducted and documented.

The ISPE GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) is available for purchase on the ISPE website.


About The Author

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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.