If a supplier is changed for the primary packing material, however, the resin and mould are same as the original supplier, do we need a stability study for same sku?

Shivam    |    24-07-2017

1 Answers:

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Mahak    |    20-08-2017

Upfront stability is not required in that case , upfront stability can only be done if change in container shape from original , change in primary packing materials and change in SKU. Its matter of supplier change only so technical and quality evaluation of supplier required only in that case and batch can be charge on ongoing stability .

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