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ICH anticipates Q&As will lead to smoother implementation

This article was originally published in The Gold Sheet

Executive Summary

The ICH Quality Implementation Working Group has developed a question-and-answer guide to help manufacturers implement its Q8, Q9 and Q10 guidelines. The Q&A has three QbD topics: design space, real-time release testing, and control strategy. ICH announced that "the benefits of harmonizing technical requirements across the ICH regions can only be reached if the various Q-ICH guidelines are implemented and interpreted in a consistent way across the three regions." The document was approved by the ICH Steering Committee as a Step 4 document on April 14

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