Max Bulk Hold Time without a stability study?

[Cheryl ML]

#26159

Hello Stabilitarians!
I wonder if anyone can help me find a reference for the maximum allowed bulk hold time without a formal stability study (for the time between production and filling) Note: I’m specifically working with liquid and semi-solid topical OTCs.
In “The Handbook of Stability Testing in Pharmaceutical Development (Huynh-Ba)” Section 3.5.2 says “For a stable drug product, it is generally acceptable that no formal study is needed if in-process materials are held less than 30 days. For unstable products or materials that need to be held longer than 30 days, stability studies are necessary…” but I can’t find where in the primary resources (ICH guidelines, etc) any actual number of days are listed. Does anyone have any insight (and specifically primary references to support my final decision).
Thank you!

[John O’Neill]

#26160

Hi Cheryl,

Turns out we have a pertinent article on the topic right here in StabilityHub written by our European correspondent Piero De Filippis.: https://stabilityhub.com/2021/11/03/ema-guidance-on-stability-studies-for-bulk-product-storage-support/ He includes 5 references as examples of which Guidances do and don’t address the issue.

That said, what do our knowledgable subscribers have to say on the subject?

[Author]

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