Conforms to GAMP 5 concepts and terminology
The International Society for Pharmaceutical Engineering (ISPE), a US authority on best practices for the pharmaceutical industry, has issued updated and expanded guidance to help pharmaceutical companies maximise testing efficiency of computerised and software-based systems that affect patient safety, product quality and data integrity.
The second edition of the GAMP Testing Guide has been revised to conform with GAMP 5 concepts and terminology and reflect ICH Q8, Q9 and Q10, Quality by Design (QbD) and Process Analytical Technology principles. It has also been expanded to include information on cloud computing, automated testing and non-linear 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,’ said 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 lifecycle.’
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 minimise duplicated effort. It also 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 guide is available for purchase on the ISPE website.