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
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