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Qualification

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by Valentina, May 7, 2020.

  1. Valentina

    Valentina New Member

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    We recently buy a new packaging format for a qualified packaging line for syrup. what kind of qualification activities we have to repeat? A performance qualification is sufficient or we have repeat some oq test?
     
  2. yodon

    yodon Well-Known Member

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    Not really sure about food regulations but maybe this helps get the conversation started.

    First, what do your internal procedures say about what re-qualification activities are needed?

    Second, what was the scope of the original qualification? Was it over a range of processing parameters or very limited to exactly what you're currently doing?

    Third, what are the changes that are needed to accommodate the new packaging format? What are the risks to the product based on the process / changes?

    Generally, in the absence of any internal procedures, I'd think you'd let your risk assessment drive the efforts.
     
    Andy Nichols likes this.

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