Record Retention For Manufacture of components

KarenA01

Involved In Discussions
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:
3.11 medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use <snip> intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) <snip>

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:

The organization shall retain the records for at least the lifetime of the medical device as defined by the
organization, or as specified by applicable regulatmy requirements, but not less than two years from the
medical device release by the organization

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
 

Enghabashy

Quite Involved in Discussions
*as I understood it's reagents & i's not device component ; anyhow it has expiration date , the retention time should cover at least guarantee; expiration date , relevant regulation & requirement above , technical /safety data sheet which declared by the manufacture ;
* the other issues under studying as controlling the batches & the shipments from your suppliers ; the retention time of records & data of each shipment should be specified for effective tracing in future & any market 'received issues
 

Billy Milly

Quite Involved in Discussions
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!

Requirement above is related to design documentation - you should archive everything related to design until you produce the device (item) + a few more years. Production documentation (related to a specific batch) should be stored for the lifetime of device batch + a few more years. You also have to respect the relevant legislation (MDR, for example, explicitly requires storing for 10 years from production date for consumable devices).
 
Top Bottom