Lot Release Test and Certificate of Analysis

#1
Dear all,

Does anyone know, for a typical sterile single use medical device, what test items are mandatory for lot release test?

I am from south east Asia and we have a product in the process of 510k. I found an earlier post which said it should be based on risk, so does that mean that the manufacturer decides what items should be tested based on risk analysis?

Also, for Certificate of Analysis, do we just put all the lot release test information on it? Or do we choose what we deemed important and only put those on CoA?

A couple of newbie questions, since I am really new to US market.

Much appreciated to all!
 
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chris1price

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#2
Regarding lot release, it is for you to decide the final acceptance activities. The requirements should be documented and the results held in the DHR. Take a look at 21CFR820.80(d) for further information.

The CoA (or CoC) is often has little meaningful information on it. If your customer requires specific information, then add it to the certificate, otherwise keep it simple. Note that for devices under 21CFR820, there is no requirement for a certificate.
 
#3
Regarding lot release, it is for you to decide the final acceptance activities. The requirements should be documented and the results held in the DHR. Take a look at 21CFR820.80(d) for further information.

The CoA (or CoC) is often has little meaningful information on it. If your customer requires specific information, then add it to the certificate, otherwise keep it simple. Note that for devices under 21CFR820, there is no requirement for a certificate.
Thank you! It is very clear!
 

chris1price

Trusted Information Resource
#4
Having thought a little deeper, one part of lot release that is essentially mandatory is for the manufacturer to review the sterilisation data. This is, especially true when the sterilisation is performed by a sub-contractor. This would also be true of any external work that is part of the release process.
 
#5
Having thought a little deeper, one part of lot release that is essentially mandatory is for the manufacturer to review the sterilisation data. This is, especially true when the sterilisation is performed by a sub-contractor. This would also be true of any external work that is part of the release process.
Thank you again!

Please correct me if I'm wrong, "review the sterilisation data" does not mean sterility test, does it? I guess you mean the sterilization batch record?
 

chris1price

Trusted Information Resource
#6
Sorry for the confusion, I mean the data sent by the sub-contractor (times temperatures, pressures, dosage, etc). It is your responsibility to review it and ensure it meets specifications; and don't forget to document the review.
 
#7
Sorry for the confusion, I mean the data sent by the sub-contractor (times temperatures, pressures, dosage, etc). It is your responsibility to review it and ensure it meets specifications; and don't forget to document the review.
Yeah, that is what I imagined what you meant. Thank you!
 
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