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Guidance Document: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) - ICH Topic Q11 - Figure 6 Text Description: Risk Ranking of Ion Chromatography Process Parameters

Bar diagram with three types of lines. Bold line indicates extension of ranges would normally initiate regulatory post-approval change process, grey line indicates the applicant can include in the original submission a proposal for extension of ranges for these parameters, and white line indicates extension of ranges is addressed primarily via the PQS (Q10). The ranges from left to right are lower risk to higher risk.

Feedstock conductivity (A) and Feedstock pH (B) are black lines considered higher risk. Load density (C) is a black line medium-high risk. Buffer conductivity (D) is a black line slightly lower risk than C. Feedstock impurity level (E) and Parameter X (F) are black lines with slightly lower risk than D. Resin Age (G) is a grey line with medium risk. Flow Rate (H) is a grey line with slightly lower risk than G. Parameter Y (I) is a grey line low-medium risk. Feedstock salt composition (K) and Buffer Salt Composition (L) are white lines with lower risk. Buffer Titrant Concentration (L), Resin Lot (M) and Temperature (N) are white lines with lower risk. Feedstock titrant (O), Biotechnology product concentration (P), Cleaning buffer (Q), Start of Pooling (R), End of Pooling (S), Parameter Z (T) are all white lines with very low risk.