1.

Is Grouping Of Products In The On-going Stability Program Acceptable?

Answer»

Grouping or bracketing could be ACCEPTABLE, if appropriately scientifically justified and if the formulation is (nearly) IDENTICAL. This will be ASSESSED during inspections on a case-by-case basis.

Grouping or bracketing could be acceptable, if appropriately scientifically justified and if the formulation is (nearly) identical. This will be assessed during inspections on a case-by-case basis.



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