DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record

C

CreMindES

#21
I want to add that IMHO the only way to make it cause as little pain as possible, is to make sure it also helps your development and documentation, ensuring that it only adds minimal extra effort to maintain it.
 
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R

rdesmond

#23
Hello. We are a contract manufacturer. When we perform Process Validation, should we place the protocol & report in our DMR or DHR? Of course, our customer receives a copy for their DHF, however I wasn't sure for ours. I assume?? the same answer will also hold for Equipment Qualification protocols & reports, yes? Thanks a bunch!!:bigwave:
 
M

MIREGMGR

#24
Hello. We are a contract manufacturer. When we perform Process Validation, should we place the protocol & report in our DMR or DHR?
In your part of the device DMR.

As a contract manufacturer, you have primary responsibility for those aspects of your processes that are proprietary to you and therefore not fully controllable by your customer(s). Records related to your responsibilities go into your DMR for the product. Your customer also has a DMR for the product, containing records for those matters that they control and that they source on the outside and can effectively control, such as design and (in some cases) materials qualification.

The DHF is maintained by the party responsible for the device design, and contains information on that design from the beginning and including all iterations, modifications and developments, but usually doesn't include the current product design which is documented instead in the DMR.

The DHR is maintained by the party responsible for manufacturing, or in a contract manufacturing relationship, sometimes jointly and sometimes in duplicate fashion by the customer and the contract manufacturer respectively.
 

Ronen E

Problem Solver
Staff member
Moderator
#25
Hello. We are a contract manufacturer. When we perform Process Validation, should we place the protocol & report in our DMR or DHR? Of course, our customer receives a copy for their DHF, however I wasn't sure for ours. I assume?? the same answer will also hold for Equipment Qualification protocols & reports, yes? Thanks a bunch!!:bigwave:
Definitely not in the DHR.

IMO also not in the DMR.

I think you could simply create a file designated "Process Validation & Equipment Qualification", and keep it there, as simple as that. Just make sure all your SOPs are aligned with that arrangement, and that any one with proper clearance (FDA, your staff etc.) is able to gain access to these documents quickly and effortlessly, for as long as required. See also my previous post in this thread.

Contrary to common belief, regulation doesn't have to go against common sense.

Cheers,
Ronen.
 
H

Huyen

#26
Definitely not in the DHR.

IMO also not in the DMR.

I think you could simply create a file designated "Process Validation & Equipment Qualification", and keep it there, as simple as that. Just make sure all your SOPs are aligned with that arrangement, and that any one with proper clearance (FDA, your staff etc.) is able to gain access to these documents quickly and effortlessly, for as long as required. See also my previous post in this thread.

Contrary to common belief, regulation doesn't have to go against common sense.

Cheers,
Ronen.
Dear All,

We just produce the sample of medical device for Customer from US (we are from Vietnam). Our company plan to certify FDA in next year. However, when Customer audit us, they ask to have DHR procedure inplace, we are almost unclear about it, Can anyone help to share the format or template of it
Must appreciated ..
 
L

lfrost

#27
"Dear All,

We just produce the sample of medical device for Customer from US (we are from Vietnam). Our company plan to certify FDA in next year. However, when Customer audit us, they ask to have DHR procedure inplace, we are almost unclear about it, Can anyone help to share the format or template of it
Must appreciated .. "


The DHR, and all of it's components, tells how the device was made to the specifications of the DMR. The DMR, and all of it's components, tells how the device was manufactured to the specificatons of the DHF. The DHF tells of the steps taken to design the device.

You should be aware that your device needs to be listed and registered with the FDA before you market your device in the USA. You do not need to "certify" your device with the FDA unless it is class III or a required class II device which need a 510(k) PMA approval.

Hope this helps...:2cents:
 
L

Lulumathew

#30
Could any one help me understand what is Lot History Record? Is that same as Device History Record?
 
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