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Figure 2: QTTP and critical quality attribute (CQA) identification and line of sight.
Systematic drug development and QRM (see Figure 1 ) ensure that we maintain line of site from the target product profile, to the quality target product profile (QTTP), through CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process parameters and control selection, and finally, method and process validation (see Figure 2 ). ICH Q6, Q8, Q9, Q10, and Q11 detail the pharmaceutical development process and how to set limits (1-5). The QRM process is linked to product and process CQAs because they are the quality attributes of the drug.

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