Recommendations regarding packaging changes are listed for APIs (e.g. for deletion of one of the authorized bulk or final containers, change of a secondary packaging component of the drug substance) and for finished products (e.g. change in the name of a supplier of a packaging component). Details on testing frequency for packaging material are seen as a GMP issue; therefore all the detailed information on testing frequency for packaging material in the dossier (Module 3) should be deleted via a Type IB variation.
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