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ICH Adds More Q&As

This article was originally published in The Gold Sheet

Executive Summary

The ICH Quality Implementation Group in October added several questions and answers to its guide for helping manufacturers implement its Q8, Q9 and Q10 guidelines. One of the additional questions is: "What is an appropriate approach for process validation using ICH Q8, Q9 and Q10?" The answer: "the objectives of process validation are unchanged when using ICH Q8, Q9 and Q10. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria…As an alternative to the traditional process validation, continuous process verification can be utilized in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle." ICH also addressed the role of risk management and continuous process verification in continuous improvement, clarified that parametric release is a type of real-time release, and explained that under QbD, even with real-time release testing, the product would still have to meet traditional specifications if subjected to end product testing. The agency also clarified that under Q10, some elements of the control strategy are subject to inspection

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