ICH Q11 Development and Manufacture of Drug Substance
CH Q11 Development and Manufacture of Drug Substance
Example 2
This example illustrates how results from an iterative quality risk assessment can be used to
communicate the rationale for classification and proposed future management of changes to
process parameters.
Risk Ranking of Ion Chromatography Process Parameters
Feedstock Conductivity (A)
Feedstock pH (B)
Load Density (C)
Buffer Conductivity (D)
Feedstock Impurity Level (E)
Parameter X (F)
Resin Age (G)
Flow Rate (H)
Parameter Y (1)
Feedstock Salt Composition (J)
Buffer Salt Composition (K)
Butter Titrant Concentration (L)
Resin Lot (M)
Temperature (N)
Feedstock Titrant (0)
Biotechnology Product Concentration (P)
Cleaning Buffer (Q)
Start of Pooling (R)
End of Pooling (S)
Parameter
(1)
Lower Risk
TT
ПОДДО
Higher Risk
Extension of ranges would normally initiate a
regulatory post-approval change process
The applicant can include in the original
submission a proposal for extension of ranges for
these parameters
Extension of ranges is addressed primarily via
the PQS (Q10)
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