I work for a biotech company that produces biologics (enzymes etc). We are workin on our first product and have 13485 and don't have a design exclusion, however we don't make medical devices or in vitro diagnosis kits. At most company who do such things would buy are products, however other customers (most?) will not be using them for medically related purposes...
Now my question...
We are working to bring our first product to market... What has to be done tduring Validation phase?
I think the R&D people want to just do the testing on material produced during production scale development, when there was no approved validation protoco nor final batch records.
They wanted to declare the last development lots as potential product and only want the validation phase to consist of doing formal release testing on lots produced produced during development - this is before formal approved final product batch records that worked do into the Product File (Device File) are created...
Coming from Pharma by understanding is that the Validation stage of product development is about the whole process... In that once R&D develops a process, the validation phase costs of making the lots specifically to be validated specifically as part of the validation phase and not just testing lots made during the development of the manufacturing processes.
Their view is that that can take the lots created during development just do the formal release testing... and the validation protocol would be just about that.
It seems to me manufacturing biologics has more in common with Pharma processes than devices, and in Pharma we actually had to make the validation lots AND test them, as part of the formal validation. Thsi was after all manufacturing processed were finalized.
Who is correct here? Under 13485 can the development stage lots be used for validation event though the process was not locally finalized and validation protocol not written and the validation phase only consist of testing those lots?
Thanks,
-Karen
Now my question...
We are working to bring our first product to market... What has to be done tduring Validation phase?
I think the R&D people want to just do the testing on material produced during production scale development, when there was no approved validation protoco nor final batch records.
They wanted to declare the last development lots as potential product and only want the validation phase to consist of doing formal release testing on lots produced produced during development - this is before formal approved final product batch records that worked do into the Product File (Device File) are created...
Coming from Pharma by understanding is that the Validation stage of product development is about the whole process... In that once R&D develops a process, the validation phase costs of making the lots specifically to be validated specifically as part of the validation phase and not just testing lots made during the development of the manufacturing processes.
Their view is that that can take the lots created during development just do the formal release testing... and the validation protocol would be just about that.
It seems to me manufacturing biologics has more in common with Pharma processes than devices, and in Pharma we actually had to make the validation lots AND test them, as part of the formal validation. Thsi was after all manufacturing processed were finalized.
Who is correct here? Under 13485 can the development stage lots be used for validation event though the process was not locally finalized and validation protocol not written and the validation phase only consist of testing those lots?
Thanks,
-Karen
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