Ongoing/Annual stability studies in commercial pack

[pankaj.jain@alvotech.com]

#26639

when the commercial product is packaged in different packaging configuration, like 1 vial/pack, 3 vials/pack, etc. but drug product inside is the same, only the number of containers are different in each pack type.

ICH Q1D, specifically talks about bracketing of product strengths and not the packaging type. Is it really needed to perform annual commercial stability for all packaging configurations? or any bracketing be applied or any one configuration be picked up.

please help.

[John O’Neill]

#26664

Check with the regulatory authorities with a plan you propose. Go with data to show there is no influence on stability outcomes if you have “non-threatening” differences in outer packaging; For a conventional product, something like 3 months at 40C/75%RH for both scenarios could do it. Run it by your Quality and Regulatory Units in house before moving forward.
John O’Neill

[Author]

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