The
World Health Organisation has published a second draft on the “Revision of its
Process Validation Guideline”.
The
main change is with the chapter "process qualification". Here it is
stated that a risk assessment is required for the change in batch size from
scale up to commercial batch size. Explicitly, manufacturers are requested to
implement the new validation approach. However, it is mentioned that full
implementation may take time. In the interim, the traditional approach or
concurrent validation may be accepted. Also a hybrid approach (based on a
scientific basis and risk management principles) may be an alternative.
Posted by Tim Sandle
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