We're in the process of submitting information to Health Canada to support a licence application and I'm aware that there may be a requirement to generate data supporting the stability of our Class III device at low temperatures, i.e. below freezing - when product may be on a airport runway.

Does anyone on the forum have any experience/could point me in the right direction as to the best way to proceed.

We don't currently have any data regarding the stability of the product below 2-8°C.

Many thanks
Jampot

Are you in the process of, or planning to, collect the data you need?

If the problem is the absense of a standardized test method or protocol for what you need to do, I'd think you'd want to make up a test method of your own. Better to have somewhat-valid data indicating that you've made an effort to address an issue, than no data at all.

Or am I missing a key technical or regulatory point?

We submitted a class III license application to HC recently and are still waiting for the review process. We provided the lab testing reports to them, hope it is helpful because mostof the testing items have been covered by the lab to comply with the recognized standards.

going by your post... it looks like, you are referring to transport-validation;

the unique/specific conditions of CANADA would make it logical for anticipating an query on relevant data.

essentially an study designed with identification of the conditions, parameters to be evaluated, suitable methods and acceptance criteria, along with justification for each component.

have a look at the following guidance from HC.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069_temp_control_dproducts_storage_transportation_ltr-doc-eng.php
http://www.micomlab.com/impact-eng/cold_chain_validate_temperature.pdf


hope that helps.
valiveti

Dear v9991,

Thanks for your information. However, did you note that the initial posted question is related to a Class III medical device according to CMDR? The information you provided and talked is pharmaceutic products.

thanks luloo117117.. ... i guess i forgot to add that disclaimer...:o

now, in general terms transport stability is intended to be used for assessing the damage to products [wrt effectiveness of package..];

but, here jampot is mentioning about "...stability of product below 2-8 deg...airport..runway...etc.," hence, i have safely assumed that he is talking about the evaluation of the product [most probably physico-chemical terms...] and i was trying to provide nearest possible references for the same.

anyway, thanks for helping me put the post in-to the right-context.
valiveti.

Many thanks for this useful guidance. I'm grateful.

you are welcome jampot;
just to confirm the follow-up actions you have implemented...it will be great,

if you can clarify your exact requirement;
or what is the feedback from Health Canada on your submission document
or even what are your plan of actions...