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What are the requirements of traceability in FDA's Regulations


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  Post Number #1  
Old 24th August 2008, 01:40 AM
hafor's Avatar
hafor

 
 
Total Posts: 8
Question What are the requirements of traceability in FDA's Regulations

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks

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  Post Number #2  
Old 24th August 2008, 02:31 AM
MIREGMGR

 
 
Total Posts: 3,681
Re: what are the requirements of traceability in FDA's Regulations

Is your inquiry in regard to Traceability per 21 CFR 820.65, or Device Tracking per www.fda.gov/cdrh/devadvice/353.html and 21 CFR 821, or general operations with critical raw materials that are obtained in batches and are known to have a potential for significant batch-to-batch variation?
Thanks to MIREGMGR for your informative Post and/or Attachment!
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  Post Number #3  
Old 24th August 2008, 02:43 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
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Re: what are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Traceability, as mentioned by MIREMGR is covered by 21 CFR 820 under Sec. 820.65 and states as below -

Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

So going back to your earlier question, all concerns with the raw material (incl Material review Board recommendations) should be part of Device History Record (DHR).
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #4  
Old 24th August 2008, 03:14 AM
harry

 
 
Total Posts: 6,271
Re: What are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Welcome,

I am assuming that you are still new and will guide you through our search feature. Just go to search, then advance search and key in 'fda + traceability' as key words and you will get the following:

Identification and Traceability in Medical Device Tracking - FDA Requirements


Procedure on Traceability - FDA audit finding
Thanks to harry for your informative Post and/or Attachment!
  Post Number #5  
Old 24th August 2008, 11:10 AM
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hafor

 
 
Total Posts: 8
Laughing Re: What are the requirements of traceability in FDA's Regulations

Thanks a lot for all of your answers.
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