Hi…is it possible to remove the in process tests from QC like pH and color and clarity …those are tests are checked in production Dept then how it controls and how can us justified in change control
I think NO because final testing must be done by quality control.
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But sir they are already done how can we justification in change control and dmf submission…
based on the criticality, if it can’t affect quality of product at any level of pH, but should be required technically supported document and move initially three batches plant scale through planned deviation , prepare the compilation data , can move to wards to change control but finally random analysis by quality control must be required.