Sterile Packaging Validation Requirements - Accredited Laboratory or not?

P

phloQS

#1
Dear all,

First of all to the forum moderator: If this thred is in the wrong forum please feel free to move it. Sorry if so! I have a question regarding our packaging validation. Per ISO 11607-x the validation for sterile packaging is defined and we have to validate our process in accordance with tht standard. Because we are a small company, we do not want to do this testing on our own (we do not have the equipement to perfom seal strength testing etc.). Our packaging supplier has such an equipement and offers validation services for all of their customers. The prices are not really cheap in my opinion. The problem I found is, that they are not accredited according to ISO 17025. They have their validation service under their 13485 certificate scope.
In my understanding we are responsible to ensure that their test methods are in compliance with the standards used to do our required test because they are not accredited. Is that a correct understanding? Do we have to perform a supplier audit, or would it be ok just to check the validation of their test methods by documentation? I am especially asking for the validaiton of packaging for the US-market. I know that in the european market a non accredited testlab under a 13485 certificate would be accpeted.

Thanks for your answers

phloQS
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Packaging validation accredited laboratory or not?

US FDA has no stance on ISO 17025 vs. ISO 13485. A medical device manufacturer that markets in USA must conform to 21CFR 820 and related requirements; that manufacturer's suppliers of materials and services must be qualified by the manufacturer, but that qualification need not include any particular QS approach as long as what they do for the manufacturer is consistent with that manufacturer's medical devices being safe and effective.

You of course reasonably could consider that a supplier having an effective ongoing ISO 17025 or ISO 13485 QS has thereby satisfied some of your requirements for qualification.

In my understanding we are responsible to ensure that their test methods are in compliance with the standards used to do our required test because they are not accredited.
The point is not specifically that you must assure they conform to a standard as a goal in itself. Rather, it's that you are responsible for what they do for you, and for your devices being safe and effective. Of course, if your devices are subject to a 510(k) and you declared compliance to a particular packaging standard as part of that 510(k) process, it's appropriate for you to assure that processes being done on your behalf continue to conform to that standard. But, conformance to that standard isn't the end goal.

Do we have to perform a supplier audit, or would it be ok just to check the validation of their test methods by documentation?
You don't have to perform an on-site audit, but you do have to be sure that their operations are consistent with your qualification of them. If you are sure that you can accomplish that via a documentation review, you may do that. As an alternative, you could choose to rely on a third party's on-site audit, i.e. reference to the international-QS-standard certification process.
 
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