Pharmaceutical industry officials recently explored how a performance-based approach to defining the established conditions for manufacturing processes outlined in the International Council on Harmonization's draft Q12 guideline could open the door for more use of process analytical technologies.
The performance-based option could provide a more efficient way to manage post-approval changes by reducing the number of changes that need to be reported to regulators, proponents said March 5 at a meeting sponsored by the International Forum and Exhibition on
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