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In 2015, ISO published ISO 90012015, a significant revision to the ISO 9001 Quality Management System standard. This 2015 version contained extensive changes and a new structure. This revision to ISO 9001 raises the question of whether ICH Q10 should be reviewed and potentially revised, and whether ICH Q10 continues to meet the ISO 9000 principles. This article assesses whether the changes to the ISO 90012015 standard could make a revision of the ICH Q10 guideline necessary and whether ICH Q10 still represents a current model of a pharm
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