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Good Manufacturing Practices Q&A

  •   As a manufacturer, can we send a sample of an in-house blend to a lab for a Certificate of Analysis (COA), then take the same sample and use it as a calibration sample for our FT-NIR machine? Thereafter, could we test future in-house blends of the same product against the calibration for identification—then prepare a COA based on the positive ID, along with the lab’s results on file, and send this to our customers?

    Answered September 1st, 2010 by Expert: Mollie Kober

    First, let me make two points. One, the FDA says that the testing used must be “scientifically valid”—one of the few places in the CFR regulations where validation is used. Second, whatever you choose to do for testing (and the FDA leaves quite a bit of leeway here) must be defensible to the FDA auditor.  You should keep those points in mind when designing your testing plan. So let’s take your proposal step by step.

    The first part of your question seems to say that you want to use outside lab data in order to qualify an in-house reference standard that will be used for identity testing via FTNIR. This would certainly be allowable. Creating in-house reference standards is a common practice. You may choose to get multiple analyses done in order to qualify that standard and that would be recommended.

    The second part of your question involves preparing a COA. You certainly could use your qualified in-house reference standard in your identity test method and report those results on a COA for your product. Your identity test method would need to be validated for the type of blend you are producing.

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