Accelerated data enough to claim 3 years and be on the Market?

M

musichismo

#1
Dear fellow colleagues in the medical device field,

We have a skin product ready and classification will be IIb.
At this moment we only have accelerated stability data, only performed on 1 batch, results are good.
Can we already commercialize the product and have it on the Market?
Can we claim a 2 or 3 year expiry date shelf life for the product and be on the Market with only results from the accelerated study.
We commit ourselves to start up stability according ICH, long-term, 3 batches, etc.

Are there any regulations pointing at this in de ISO13485 or other guidelines that tell what is necessary to be on the Market regarding shelf life/aging data?

Kind regards
 
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R

Rob Udo

#2
Hi,

I'm not aware of any specific standards. You don't give information whether the accelerated aging was done for 1,2, or 3 years simulated aging.

Common practice is to claim e.g. one year based on your accelerated aging results. It should be part of your risk assessment whether you feel comfortable with the performed testing in order to justify your claim. Make sure that you feel comfortable with a sample size of one. Also considere shelf life claims of similar products in the market and use that information to justify your decision. In that case you should be able to demonstrate equivalence of the product (materials used), sterilization method (if applicable), packaging configuration.

Based on real time aging results for 2 year, you can extend the shellf life to 2 years. You can start a 3 year study simultaneously. Make sure that you document your shelf life study in an aging plan, and stick to it.

Be aware that it is not only about stability testing. Also consider packaging integrity.
 
#4
From all the standards that are available the best one to use is:
ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Systems for Medical Devices.
It is not perfectly-matching your case but it is the best in our market segment and it is a consensus standard.
 

Michael Malis

Quite Involved in Discussions
#5
Having just an accelerated data on 1 batch to claim 3 years for Class IIb product is not enough!

You must have at min. 3 batches with accepted Functional and Package integrity tests of accelerated data to claim the appropriate shelf life for your product. Also, the accelerated test mustbe followed with the Real Time Data. If you don't have a real time data, - you can have a real problem with the product because accelerated data is still is only simulation of the real outcome!
 

Sam Lazzara

Trusted Information Resource
#6
Hello Michael,
Can you please let me know the standard/guideline that has the 3 lot/batch requirement you refer to (for medical devices)?
I did see a 3 lot/batch guideline on the ICH website for pharmaceutical stability testing, but have not yet found such a written guideline for devices.

Thank you.
 

v9991

Trusted Information Resource
#7
First :- ICH Q1E specifies that maximum shelf assigned can be either 2X or x+12 whichever is lower (X- no. of months of stability in real time). You might need to check its applicability to medical devices.

Second - Reference of 3 batches of stability, from the pharma perspective, these stability batches are part of validation program; where these validation batches are charged for stability; I think these details are covered in CTD format of regulatory submissions as well.

hope that helps.
valiveti.
 
G

gholland

#8
FDA is starting to back away from the 3 lot thing, they are much more interested in the variability of the product/process being tested. If you can justify that you capture all of the variability in the product and process with one lot... not likely but you never know... then you can go with one lot. You have to have a solid justification for your sample size.

Our company sets shelf life on accelerated aging results but also completes real time aging results as confirmation of the aging tests. We run at risk assuming that accelrated aging will be much rougher on the packaging and product than sitting on a shelf for 3 years.

For a 3 year shelf life claim you need 3 year accelrated aging data, your original post wasn't clear what kind of data you have. You can't claim 3 year shelf life on 1 or 2 year aging data.

:2cents:
 
W

wendyzeng

#9
FDA is starting to back away from the 3 lot thing, they are much more interested in the variability of the product/process being tested. If you can justify that you capture all of the variability in the product and process with one lot... not likely but you never know... then you can go with one lot. You have to have a solid justification for your sample size.

Our company sets shelf life on accelerated aging results but also completes real time aging results as confirmation of the aging tests. We run at risk assuming that accelrated aging will be much rougher on the packaging and product than sitting on a shelf for 3 years.

For a 3 year shelf life claim you need 3 year accelrated aging data, your original post wasn't clear what kind of data you have. You can't claim 3 year shelf life on 1 or 2 year aging data.

:2cents:
Thanks for your information!
 

v9991

Trusted Information Resource
#10
I am certainly NOT into devices; hence following queries.

1) on FDA moving away from the 3 batches-->''focus on variability...";
can you pl provide any reference for your note with specific reference to stability data? ; btw, what are the regulatory guidance/references for carrying out stability studies of medical devices?

I have found similar note on waiving the process validation requirements... that is more specific and to 'devices'and perspective of "Quality by Design" and modern manufacturing and analytical technologies.this can be found in CPG...
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm

IX. ACCEPTABILITY OF PRODUCT TESTING
In some cases, a drug product or medical device may be manufactured individually or on a one-time basis. The concept of prospective or retrospective validation as it relates to those situations may have limited applicability, and data obtained during the manufacturing and assembly process may be used in conjunction with product testing to demonstrate that the instant run yielded a finished product meeting all of its specifications and quality characteristics. Such evaluation of data and product testing would be expected to be much more extensive than the usual situation where more reliance would be placed on prospective validation.


2) ; but isn't it obvious that evaluating the device on stability implies that it should not be just on shelf but it must be actually operational as it is intended to be used( atleast a simulated environment of operation). And why do we treat that as accelerated condition.
(if i can mention a simple-equivalent example here; if we need to prove the shelf life of TV, then its obvious that you would subject it to 'usage' for specified time for the stated shelf life time; and accelerated condition is something like operating in various temperature/power/... fluctuation conditions)

thanks in advance for clarification.
valiveti.
 
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