I am sure you must have logged this event as per your system and conducted a detailed investigation on it. Based on the investigation if this is determined to be a definitive isolated case than QC test may not be essential.
Again based on the product and it's application you will have to determine the severity of more such low filled kit before you reach to any conclusion. If there is a probability of more such failures and /or if severity of it is medium to high you should go for an additional QC check. FMEA helps here.
My answer is based on the assumption that QC checks could detect the type of failure we are discussing here.
Hope this helps.
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Rashida Najmi, Sr VP
Quality, Regulatory and Pharmacovigilance
Piramal Enterprises Ltd
Bethlehem PA
USA
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Original Message:
Sent: 13-Dec-2018 15:34
From: Anonymous Member
Subject: Rework by vendor
This message was posted by a user wishing to remain anonymous
Hello,
I have a couple of questions on the following scenario…
- During destructive/performance of a customized kit a vendor manufactures for us it was determined that one reagent was short-filled. This reagent is one of many off-the-shelf reagents included in our custom made kit. We've determined this one reagent is the only reagent that was short-filled. The vendor will rework our kit by adding more reagent from the same bulk lot. This said, what is your recommendations regarding the following:
- Should my company perform another functional QC test? Unfortunately, I don't have a risk assessment to refer to answer this question. My technical team says no, but I would recommend a Memo to File minimally to document.
- Should my company require a new kit lot to be assigned?
Thank you in advance.