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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
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