We have an approved contract packager that blister packs samples of an immediate release tablet. The site has a satisfactory GMP rating. We'd now like to add this same site as an alternate site for packaging in bottles (no change in packaging materials used at the currently approved bottle packaging site). The site has only just recently added a bottle packaging line so they have never packaged in bottles previously.
1) Would FDA need to re-inspect the site since bottle packaging is a new type of operation or would the current GMP rating suffice since it is the same dosage form? Note the Changes to an Approved A/NDA guidance (Attachment B) does not consider primary packaging to be a type of operation, but rather goes more by a specific dosage form.
2) What type of supplement would be required? A prior approval since the site has never been inspected for this type of operation? Or a CBE-30 per section VI.C.1.c of the Changes guidance?
3) I don't believe stability data would be required – only a commitment to put the first batch on stability.
Would appreciate any and all thoughts.
Thanks in advance.
Tom
Chicago