We make biology through fermentation and do both contract manufacturing develop our products
Some of what we produce could be use as reagents in a medical devices as well as as components for vaccines . We don't need to be 13485 but management feels that getting certified for it (we just got 9001 certified a few months ago) woudl help attract customers both for oncoportaing our products into their devices as also make vacinnine makers more comfortable for contract manufacturing as it woudl mean we are "GMP Like" for manufacturing.
We met with a consultant yesterday who told us that for the purpose of certification. The "reagents" we make would considered to be devices fr compliance to te standard, as in 13485 it defines a medical device as:
But as we would not be selling a device (or anything directly for use with people) it makes figuring out how to implement some requirements a bit tricky.
In terms of record retention in 4.2.5 Control of Records, it says:
I interpret that as the lifetime of the physical device. Meaning you need the to keep the manufacturing records for a unit for at least as long as that specific unit could be in use and all least 2 years from sale.
As we would be likely assigning an expiration date to the lots of reagents so that would be the "lifetime of the device", and if a customer did their own stability study they would specify the retention time they want in the quality agreement. In fact we for ISO 9001 we said we would keep the batch records for at least 1 year after expiration and if we specified at least 1 year after expiration or 2 years from sale, which eve tis once rte woudl exceed what 13485 requires/
But the consultant interprets "life of the medical device" to as as long as you keep manufacturing that device... So you if keep making teh same device for 50 years, you would need to the keep teh manufacturing records of the first device for 50 years! That does not seem right!
Is his interpretation correct?
Thanks,
-Karen
Some of what we produce could be use as reagents in a medical devices as well as as components for vaccines . We don't need to be 13485 but management feels that getting certified for it (we just got 9001 certified a few months ago) woudl help attract customers both for oncoportaing our products into their devices as also make vacinnine makers more comfortable for contract manufacturing as it woudl mean we are "GMP Like" for manufacturing.
We met with a consultant yesterday who told us that for the purpose of certification. The "reagents" we make would considered to be devices fr compliance to te standard, as in 13485 it defines a medical device as:
But as we would not be selling a device (or anything directly for use with people) it makes figuring out how to implement some requirements a bit tricky.
In terms of record retention in 4.2.5 Control of Records, it says:
I interpret that as the lifetime of the physical device. Meaning you need the to keep the manufacturing records for a unit for at least as long as that specific unit could be in use and all least 2 years from sale.
As we would be likely assigning an expiration date to the lots of reagents so that would be the "lifetime of the device", and if a customer did their own stability study they would specify the retention time they want in the quality agreement. In fact we for ISO 9001 we said we would keep the batch records for at least 1 year after expiration and if we specified at least 1 year after expiration or 2 years from sale, which eve tis once rte woudl exceed what 13485 requires/
But the consultant interprets "life of the medical device" to as as long as you keep manufacturing that device... So you if keep making teh same device for 50 years, you would need to the keep teh manufacturing records of the first device for 50 years! That does not seem right!
Is his interpretation correct?
Thanks,
-Karen
