Covering upper T°C claim with extended storage time ICH Q1A(R2)

[KazuyoP]

#21866

Hello John,

I was wondering the following: let’s suppose I’m going to start a real-time stability study for climatic zone IV (30°C). My products in scope don’t have solutions so I’m not considering RH degree. Let’s also suppose the country where I’m going to store samples is covered by CZ IV, therefore I’m going to store my samples at 30°C.

The point is: I’m going to store samples for 2Y at 30°C to claim 2Y of shelf-life, but the regulatory agency of that country is requesting a storage up to 35°C. Thefore, can I store the samples up to 3Y at 30°C to cover 2Y at 35°C (Q10 = 2)?

I’ve never find anything on this kind of reasoning on ICH Q1A(R2) for T°C, but only for humidity.

Hope I’ve been sufficiently clear :)

Thanks a lot in advance!

• This topic was modified 2 years, 9 months ago by KazuyoP.

[John O’Neill]

#21869

Hello fellow Stabilitarian,

I see you have addressed your question to me, but I would encourage all interested parties with knowledge and experience along these lines to comment.
Based on my understanding of your description, here are my thoughts:
Your products are not liquids, but before ruling out RH studies, is your packaging semi-permeable to moisture, which could eventually impact your product? If yes, then perhaps consider adding an RH component to your study.
Your target country of marketing is requesting up to 35C long term storage. Your company’s regulatory affairs professionals may be able to negotiate an accptable plan with the regulatory authorities of your target country, but I think it likely that the authorities will hold to their requirement. Testing for a longer period at a lower temperature is not likely to reach the critical point at which your product’s degradation trajectory will change. You may propose however, using accelerated testing in conjunction with long term data as an alternative. An older FDA Guidance “Expiration Dating and Stability Testing for Human Drug Products” contains the following excerpt: “Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years. This can be done, as an example, by taking a sample product that has been at room temperature for one year and subjecting that sample to accelerated temperature conditions. The expiration dating period used would then be the sum of that justified individually at each storage condition.” Keep in mind though, that this was about shelf-life extension, rather than extrapolation based on less stenuous conditions. Your regulatory affairs professionals will need to evaulate any alternate approaches in conjunction with the authorities in your target country. I wish you success.
What do others think?
J. O’Neill

[KazuyoP]

#21870

Dear John,

Thanks a lot for you clear answer.

We’ll try to combine an accelerated storage condition (with reference real-time at 35 °C) with an extended real-time 50% longer to see if they will accept our “worst case” proposed conditions.

p.s. RH is ruled out since packaging is non-porous and systems within are completely dry

Thanks for your support again, waiting for other opinions.

KR

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