A Proposal for a Comprehensive Quality Overall Summary
ISPE
MARCH 29, 2023
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005ā2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Currently, it takes time and/or communications (e.g., 2005Nā0262) Federal Register (2005).
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