Postapproval packaging changes

For an approved application (NDA, ANDA, or BLA), a change to a container closure system, to a component of the container closure system, to a material of construction for a component, or to a process involving one of the above must be reported to the application. The filing requirements are specified under 21 CFR 314.70 (supplements and other changes to an approved application) for an NDA or ANDA, and under 21 CFR 601.12 (changes to an approved application) for a BLA. 

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Table 6 Stability Data Packages to Support Postapproval Changes... 

Table 1 Stability data package types to support a postapproval change...

Because of FADAMA, the SUPAC process has been extended by the FDA to include sterile dosage forms, analytical methods, product labeling, and product packaging postapproval changes. 

The amount of stability data supplied will depend on the nature of the change being made. Applicants may determine the appropriate data package by consulting the Postapproval Changes section of this guidance (Section IX) and in consultation with the appropriate chemistry review team. 

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