Stability Tests for our Calibration Plates

sreenu927

Quite Involved in Discussions
Hi All..

We are using Bulk(from another company) for our Calibration plates. Based on the historical data (no complaints), they determined the shelf-life as 1 year.No shelf-life report to confirm 1 year; however no problems/complaints filed on this. Our calibration plates are labelled as IVDs and we did the stability studies (accelerated & real-time) and shelf-life is 1 year.
Now we are requesting them to do stability studies to increase this bulk's shelf-life to 2 years.

Their approach is start the stability studies from 13 months, instead of week/day 0, backing up their historical data for the first 12 months.

As per 21 cFR 820 (or ISO 13485), does this an agreeable approach???

Thanks,
Sreenu
 

Marc

Fully vaccinated are you?
Leader
Re: Stability tests

A quick "Bump". My Thanks in advance if anyone can help with this one.
 

Qara123

Involved In Discussions
As per 21 cFR 820 (or ISO 13485), does this an agreeable approach???

Both 21 CFR 820 and ISO 13485 do not have requirements for shelf-life testing. However, the risk associated with significant changes have to be assessed so it would be prudent to know if you can justify your actions with objective evidence.

Their approach is start the stability studies from 13 months, instead of week/day 0, backing up their historical data for the first 12 months.

Do you mean they will perform the stability test at the final endpoint only (24 months in this case) and no interim stability testing (e.g., 12-month)? If so, I see no issues with performing stability testing at the endpoint only as long as the bulk meets all the requirements. The only risk is that if it fails, you end up with NO data.

Q
 

v9991

Trusted Information Resource
I am not much into medical devices; but will try to address your query based on some fundamental concepts of stability studies and try to supplement it with certain references from agency.

First.
...providing shelf life based on historical data (that too based on absence of complaints!!!)
Normally, this is simply not acceptable; Complaints/absence of problems... does not support the formal protocol based study to establish the robustness/quality of product. It might be an approach to quickly ascertain the product for internal-R&D purposes; but that does not make any sense to represent process/product robustness.


However, u need to find out, if there is any other ""valid-rationale, specific to devices "" for which it might be acceptable.

Here are few references...
Overview of IVD Regulation

FDA makes sure that products have QC materials, reviews labeling for accuracy, and determines if manufacturers have protocols to ensure stability.
FAQs about Investigational Device Exemption
The sponsor should provide detailed information on device labeling in the investigational plan. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

http :// www. fda .gov /AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSubmissions/ucm046291.htm - DEAD 404 LINK UNLINKED
 
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