Bracketing standard failures

Hi All

I have a question regarding bracketing standards. 

I have run an passed a full system suit for a run, I have also run bracketing standard before and after every 10 samples.

One of my bracketing standard injections has failed in the middle of the run, but all other brackets after this failure have passed specification. Should I invalidate all samples after the failed bracket or can I invalidate the samples between the failed bracket only?  

Answers

  • Hi jonB,
    I would consult your company's SOPs.  As an instrument vendor, we do not become involved in decisions around batch acceptance or rejection- those decisions fall under the jurisdiction of regulatory agencies, your company's QA department, and your company's SOPs as a whole to determine.

    -Patrick
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