Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations
XTalks
MAY 13, 2022
Leachables are inorganic or organic chemical entities that leach into a product from packaging materials under normal storage conditions or during accelerated product stability studies i.e. simulating actual use of a product or shelf life. The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case.
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