Primary (early) stability in naked vial/PFS or in full package

[pankaj.jain@alvotech.com]

#26640

As per ICH Q1 A(R2):
Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.

This requirement is well understood for ongoing/annual commercial stability.

Does it mean that primary stability studies should also be conducted on fully packaged product and not on the naked vial or PFS primary containers?

please provide your guidance.

[John O’Neill]

#26663

Thats a fair question. You can interpret the guidance to mean full market pack, but many of us do not go beyond the unpackaged product until commercialized. The key is justification and I believe it is or was in the WHO Stability Guidance that said the commercial package is required in the registration batches if indeed it provided a protective barrier that influenced the stability outcome. That would be the basis for justifying leaving the outer package off in cases where the packaging does not interfere with air/humidity/heat reaching the internal package. This provision is very convenient for those companies that would need to ship product out for the final overpack, incurring extra time in reaching the stability chamber and exposing the product to excursions during shipment. Always get agreement with QA and Regulatory before chosing your course of action and be sure to get your practice enshrined in your procedures along with your justification.
John O’Neill

[Author]

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