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Design/Change Control Procedure - How to cope with Changes during Development?
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Design/Change Control Procedure - How to cope with Changes during Development?
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  Post Number #17  
Old 16th May 2011, 06:18 AM
Pads38

 
 
Total Posts: 767
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Quote:
In Reply to Parent Post by treesei View Post

--------------------------------------------
Below is directly from the FDA:

"Manufacturers are not expected ....................................................................and approved."

So here is the requirement. Each firm may write a procedure that covers the requirement but practically fits its own situation.
Thanks Treesai, that is a good quote.

Can you tell me which guidance document it comes from?

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  Post Number #18  
Old 16th May 2011, 07:55 AM
PaulGr

 
 
Total Posts: 44
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Hi Pads38.

The quote come from this guidance: http://www.fda.gov/medicaldevices/de.../ucm230127.htm

It is actually the FDA Response to Comments and Rationale for Changes with respect to the 820. For the specific line, see both page 52621 and page 52622.

Cheers, Paul
Thank You to PaulGr for your informative Post and/or Attachment!
  Post Number #19  
Old 16th May 2011, 10:52 AM
sagai

 
 
Total Posts: 1,132
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Guidance is the special control. I would not call the source of that quotation as a guidance.
br
Sz.
  Post Number #20  
Old 16th May 2011, 12:46 PM
treesei

 
 
Total Posts: 262
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Quote:
In Reply to Parent Post by Pads38 View Post

Can you tell me which guidance document it comes from?
--------------------------------------------------
Dear Pads38,

Certainly. It comes from the preamble of the US FDA's medical device cGMP final rule published in Federal Register Vol 65 No 195:52602-52654; 1996, available from the FDA's website. The particular quote is on page 52621.

The cGMP rules (21 CFR 820) are purposely vague. However, a lot of info that explains the rules can be found in the preamble which I recommend my colleagues to spend some time on reading. It is not formally written in the regulation but it shows how the FDA interprets the regulation.

Regards,
treesei
Thanks to treesei for your informative Post and/or Attachment!
  Post Number #21  
Old 16th July 2012, 09:21 AM
todayssunny

 
 
Total Posts: 4
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Hi Aphel,

I'm not sure if this thread is still active.
However in such a case as described by you,
our procedure requires to complete a design change form (during development / pre design transfer).
A part of this form is to assess the change impact...in your case the assessed impact would be to go back and do the change and repeat design verification afterwards.

bes regards
  Post Number #22  
Old 25th January 2018, 05:22 AM
Siddhartha230

 
 
Total Posts: 4
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Quote:
In Reply to Parent Post by Aphel View Post

Hello everybody,

Thank you for all the answeres and guesses...

The problem i have, is not to control changes in single documents (e.g. drawings), therefor we have a nice procedure (document controls).

But what are your solutions (procedures) if you have for example the following change during development:

Imagine, you just went through the milestone design freeze, you have already startet design verification. And now - during design verification you realise, that you are not able to pass a certain requirement and you are forced to make a change to a functional design input requirement.

What are your design change procedures saying in such cases?
How do you organise, manage and document such necessary changes?


Best regards,
Aphel
I also have the same question.

I don't know how to properly control the design change before design transfer, and don't know how to compile the Design History File (DHF) after the design change has been finished.
  Post Number #23  
Old 27th January 2018, 05:21 PM
yodon

 
 
Total Posts: 1,156
Re: Design/Change Control Procedure - How to cope with Changes during Development?

Quote:
In Reply to Parent Post by Siddhartha230 View Post

I don't know how to properly control the design change before design transfer, and don't know how to compile the Design History File (DHF) after the design change has been finished.
At some point, the design artifacts go under design controls. Any change after that must follow the Design Changes procedures (820.30(i)). Presumably, you already have procedures for this. Typically, a "change request" is opened then that is reviewed to determine scope and impact (especially on the Risk Analysis). The proposed changes are approved and then implemented. Some method to verify or validate the changes is defined. If you have already done any system V&V then the impact of the change on those efforts needs to be evaluated and likely some additional V&V work is warranted. The change record providing traceability to what all changed / what was done as well as the updated design artifacts become part of the DHF.

Hope that makes sense.

In the future, it might be best if you open a new thread rather than jumping on an old one.
Thanks to yodon for your informative Post and/or Attachment!
  Post Number #24  
Old 9th March 2018, 02:04 AM
QAengineer13

 
 
Total Posts: 142
Re: Design/Change Control Procedure - How to cope with Changes during Development?

After reading this page, I need some clarity related to the concept of Pre-Production change control and Post-production change control

In a design and development project, say they have an alpha build, beta build and then their Pre-production unit (PPU) build.

Before PPU build process start is when the design freeze happens and the Design verification starts.....

Is the term Pre-production change control means anything and everything related to the change control before the DESIGN TRANSFER is my understanding, correct? and Post-production is after the sucessful transfer and the Production units are built, is this correct?

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