Cleaning Validation : Defining Limits and Doing MACO ...

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PDE: Permitted Daily Exposure: The maximum acceptable intake of elemental impurity in pharmaceutical products per day. GMP Compliance EU/US – ICH Q3D §3.2 Consider the doses/exposures at which these effects can be expected relative to the adverse effect that was used to set an established PDE. 2nd: new GMP approach…

  Compliance, Elemental, Impurity, Ich q3d, Elemental impurity