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Hello, I'm new to the quality system work and have been asked to take over a lot of the package validation work, so maybe someone can help me out with this question. We have a device for which the packaging validation work has already been completed. It is a multi-layer wound care device. We added another layer to it to make a new product and we will be packaging the new product in the same packaging (poly/poly pouch). At what point does the packaging validation need to be re-done? Because this is technically a different product in the same package, does it need to be re-validated or because of the similarity and the same packaging will the old validation be sufficient?

, let's set some variables: