Better control of DHR (Design History Record) during processing

E

erniemc

#1
Hello all,

We are a biotech manufacturing facility and our DHR's are all on paper and therefore are not being carried around during processing and filled out immediately. My main question is can I make a laminated copy of the DHR that they could fill out with lot number etc and carry it around with them when information needs to be filled out? They would then transfer the data to the original paper DHR the same day. Is this a violation of any GMP procedure? Or does the laminated copy also need to be filed with the original DHR or can it be erased and then reused when the same product is manufactured?
 
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somashekar

Leader
Admin
#2
Re: Better control of DHR during processing

Welcome here erniemc ~~~
If what you describe works well and true to you, you are good.
What are the risks that you see for a missing data on the laminated sheet before it is transferred on to the paper, since you say they are erasable on the laminated copy ?
 
E

erniemc

#3
Re: Better control of DHR during processing

Thanks for the welcome!
I think the laminated copy would only be erased at the end of the process so we would be able to review it before it is erased. The fact that you say we are good is the best news to me!
 

yodon

Leader
Super Moderator
#4
Re: Better control of DHR during processing

Personally, I wouldn't want to try to defend this process. Both transferring data and destroying original data are not exactly good practices and leave you pretty exposed. Further, recorded data is expected to be done as permanent. What you describe is basically allowing original data to be erased and replaced. If you choose to go down this path, I would suggest you take extraordinary measures to ensure reliability. Maybe attach a photo-copy of the original data and attach it to the 'final' copy and have a QA rep attest that it's all good.

Side question: are you able to ascribe the recorded data to the person originally entering it?

I also don't understand - if they can carry around a laminated copy, why can't they carry around a (final) hardcopy?
 
E

erniemc

#5
Re: Better control of DHR during processing

The reason the hardcopy is not carried around is there is a lot of water involved and they are afraid they would smear the pages by wetting them. My biggest concern is exactly what you mentioned by allowing them to transfer data and not having the original copy available. The data is identified by initialing and dating the step performed on the laminated copy, so your suggestion of a photo-copy/QA approval is also good.
I am beginning to investigate if only certain procedures associated with a DHR would need to be laminated i.e. temperature monitoring every 15 minutes for 2-3 hours. This would reduce photo-copying and data transfer.
My main intent here is to get the DHR filled out properly and on time instead of a bunch of notes stuck in the DHR folder and filled out a few days later!
 

yodon

Leader
Super Moderator
#6
Re: Better control of DHR during processing

Sounds like a challenging situation and it sounds like you're well aware of the challenges (recognition is important). Another thought might be a ruggedized laptop.

Documenting your process (whatever you come up with) with the rationale for why you have to do it that way would help you should you be audited.
 
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