Sponsor name presented in the test report

Morris Liu

Starting to get Involved
#1
Hey Guys,

I am first time in a regulation affair position, and now doing some of the standard test (ISO 10993, ISO 11135, etc.) for the product.

Our company is the contract manufacturer for the related product, and after production we send product to another contract sterilizer to perform sterilizing. Because our contract sterilizer says they have another contract company can help us do the standard test, we send them samples for doing such test. Now they offer an application, which is for the standard test application to their contract company, having the sponsor name in their own company name, and only show our company name in the manufacturer.

Because the sponsor will present as a test client in the test report, I am wondering whether it will make the report does not belong to us or affect our client for applying CE or FDA, which only address the contract manufacturer in my company name.

Hope to be clarified, thanks guys.
 
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monoj mon

Quite Involved in Discussions
#2
Hello Morris,

This is not unusual to happen, so I don't see anything to worry about. There should not be a problem, as long as,
  1. The contract sterilizer combine both of their report and the third party testing lab's report. This can be done by providing the third party testing lab's report as an attachment and the sterilization company mentions it within their report.
  2. Both the original report as well as the attachment include identical test article information, such as Test article model number, LOT number etc., Manufacturing date, Expiration date etc.
 

Morris Liu

Starting to get Involved
#3
Hello Morris,

This is not unusual to happen, so I don't see anything to worry about. There should not be a problem, as long as,
  1. The contract sterilizer combine both of their report and the third party testing lab's report. This can be done by providing the third party testing lab's report as an attachment and the sterilization company mentions it within their report.
  2. Both the original report as well as the attachment include identical test article information, such as Test article model number, LOT number etc., Manufacturing date, Expiration date etc.
Hello monoj mon,

Thanks for answering. But what if the contract sterilizer won't provide any further report, only return the third party report, which the sponsor will be the sterilizer's name and product manufacturer is us. Will it affect the report attribute to the sterilizer not us?
 

monoj mon

Quite Involved in Discussions
#4
For such pre-clinical performance testing, my understanding is that any regulatory authority will not give more attention to who the sponsor is rather than what the test article is being tested.
But what if the contract sterilizer won't provide any further report, only return the third party report, which the sponsor will be the sterilizer's name and product manufacturer is us
In my opinion, in this scenario also, referring to your 'LOT Number, Model Number, Manufacturing Date, Expiration Date' shall be sufficient to identify your product. Won't they put any picture of your test article on their report!

Even if the contract sterilizer is not providing you any report, can they at least provide you a statement declaring this current scenario!
 
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