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Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. These new operating models can help enable and accelerate the efforts of Pharma 4.0™
TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.
TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.
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