The guideline applies to the risk assessment and control of leachables in new drug products, including cell and gene therapy products. Drug-device combination products that require marketing authorizations and meet the definition of pharmaceutical or biological products are also in scope.
Organic leachables are the primary focus of this guideline. Though recommended methodologies for elemental analysis are within the scope of this guideline, the safety assessment of elemental leachables are addressed by ICH Q3D and thus out of scope for this
26 guideline.
The guideline also applies to approved products for any changes that are likely to impact the leachable profile or patient exposure such as those relating to formulation, manufacturing, dosing, and/or container closure system (i.e., life cycle management). This guideline is not intended to apply to extrinsic, extraneous or foreign substances resulting from product contamination or adulteration.