R
RMPMAN
Hi,
I work for a med device company and ocassionally we'll make validated design or process changes to marketed devices. The question / debate often entails about whether or not Long Term testing (testing covering the duration and labelled shelf life and storage conditions) or Accelerated testing is required.
If real time long term testing is required, the leadtime for roll out of the project is significantly impacted (some products have 12 month shelf life) - and therefore the decision of lifetime testing is critical and must be made very early in the project.
I have often tried to make a risk based case for accelerated studies but have been given this reply:
Yes stability data for marketed products can come from accelerated conditions, but the accelerated protocol has to be validated against real time lifetime data (FDA requirement). In other words, we could validate an accelerated protocol against our current product, but as soon as you introduce a change (that impacts lifetime) to the process or product, you essentially have a new product and therefore no real-time lifetime data to support the arguments that accelerated testing mimics performance across real-time testing. Plus, although the FDA will accept accelerated testing under the proper circumstances, they still require a real time lifetime to be run concurrently.
My question, how do you determine when a change is significant enough to warrant real time lifetimes? Does every product change necessitate a new realtime study? Is there a guiding document that could provide clarity.
thanks in advance,
Julison
I work for a med device company and ocassionally we'll make validated design or process changes to marketed devices. The question / debate often entails about whether or not Long Term testing (testing covering the duration and labelled shelf life and storage conditions) or Accelerated testing is required.
If real time long term testing is required, the leadtime for roll out of the project is significantly impacted (some products have 12 month shelf life) - and therefore the decision of lifetime testing is critical and must be made very early in the project.
I have often tried to make a risk based case for accelerated studies but have been given this reply:
Yes stability data for marketed products can come from accelerated conditions, but the accelerated protocol has to be validated against real time lifetime data (FDA requirement). In other words, we could validate an accelerated protocol against our current product, but as soon as you introduce a change (that impacts lifetime) to the process or product, you essentially have a new product and therefore no real-time lifetime data to support the arguments that accelerated testing mimics performance across real-time testing. Plus, although the FDA will accept accelerated testing under the proper circumstances, they still require a real time lifetime to be run concurrently.
My question, how do you determine when a change is significant enough to warrant real time lifetimes? Does every product change necessitate a new realtime study? Is there a guiding document that could provide clarity.
thanks in advance,
Julison
