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Process validation when changing location
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Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
Process validation when changing location
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Some Related Topic Tags
process validation, validation (general), validation of machines equipment processes design etc., validation requirements
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  Post Number #9  
Old 12th March 2018, 08:18 PM
snoopy2017

 
 
Total Posts: 87
Re: Process validation when changing location

Thanks for the reply. We are not absorbing the site. The manufacturing operations were previously done at a local contractor. But we decided not to outsource this and set up manufacturing operations in house.

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  Post Number #10  
Old 13th March 2018, 05:56 AM
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Bev D

 
 
Total Posts: 3,605
Re: Process validation when changing location

If you are bringing the process in-house, process validation is the right thing to do regardless of what the standard or your Customers require. You will have different facilities, different operators, and potentially different equipment with different parameter settings. If you are changing raw material suppliers you will have to validate the different sources of material.


I still advise you to read the standard - and any Customer requirements - to further your understanding of the requirements. Then return if you have questions regarding the requirements. A simple response as to what is required will only help you ‘remember’ what to do, but it won’t help you truly understand the requirement.
Thank You to Bev D for your informative Post and/or Attachment!
  Post Number #11  
Old 13th March 2018, 08:06 AM
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ScottK

 
 
Total Posts: 2,708
Re: Process validation when changing location

Quote:
In Reply to Parent Post by snoopy2017 View Post

Thanks for the reply. We are not absorbing the site. The manufacturing operations were previously done at a local contractor. But we decided not to outsource this and set up manufacturing operations in house.
I see - my immediate reaction is that if you are in med device and you add a new process with new equipment you're going to at least have to qualify the equipment with an IQ/OQ type process.
If the output of the process verifiable? If so you may be able to get away with not doing a full process validation but you should have a risk analysis on hand to support that decision.

Whether your prior subcontractor's process was validated or not is immaterial - you now have ownership of the process with different equipment in a different setting with different infrastructure with different operators.
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