Stability Data Reporting Requirements?

[John O’Neill]

#25030

Posted on behalf of an industry colleague:

I’m exploring stability data reporting options in JMP and wanted to baseline with any formatting requirements for data tables used in regulatory filings. Google hasn’t been helpful in locating guidances; are you aware of any (FDA, EMA)?

Obvious requirements are time point, test, specification and result. Are there requirements on how this is formatted? How footnotes appear? requirements for method or detection equipment (HPLC-UV), etc. If graphical representations are utilized (linear regression) are there any requirements (r2 must be reported, etc.)

[John O’Neill]

#25031

(Response posted in behalf of Laura Pack, a well-respected industry stability statistician)

As to the data formatting, here are my thoughts / typical practices (feel free to post if you like):
– I don’t know of any guidance on stability table format specifically
– My general principle is to provide the least amount of information possible – from a lifecycle approach, this makes it easier to maintain tables when updated in case information changes throughout the course of the study (e.g. specification acceptance criteria)
– In data tables, we typically provide:
o Lot number
o Formulation / presentation
o Storage condition
o Method, attribute
o Acceptance criteria (ONLY for clinical filings and ONLY if regulatory affairs requires). Otherwise, I point to current specs in S.4.1 / P.5.1 and footnote attributes removed / limits changed for studies that don’t meet current AC
o Data formatted to specification reporting precision
– YES, I have used JMP in S.7.1 / P.8.1, but usually only in commercial applications:
o Provide regression analysis for expiry, including plots and a top-line conclusion that each attribute’s regression supports your requested shelf life
o Use ‘recorded values’ for stats analysis – the unrounded, recorded results with more decimal places are used for data analysis. Note that these recorded values are not provided in S.7.3 / P.8.3
o The raw data files for stats can be provided in ts.xpt format, similar to the way FDA expects clinical trial data to be submitted.
 FDA did request our raw stability data to be submitted in one of my recent commercial filings (it was fast-tracked and part of a few pilot programs)
 See https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber for data submission standards (applies to clinical trial data, but can be used for stability data files too)

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