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[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles). Present in sufficient quantity to achieve target concentration in process and enable defoaming.
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