Regulatory Open Forum

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  • 1.  IQ/OQ on existing equipment

    Posted 20-Aug-2017 22:15
    Some advise please,
    we have established equipment installed over 10 years ago,
    We are going to start to make Pharma products.
    Currenlty making cosmetics and nutritionals.
    Going forward with OTC proutcs put us in the need for process validation.
    How should I go about to cover retrospective IQ/OQ is third possibllity.


  • 2.  RE: IQ/OQ on existing equipment

    Posted 21-Aug-2017 08:42
    ​Hi Susan.

    Couple of options from what I see.  First, regarding the IQ - this is difficult (though not impossible) to do ex post facto.  Best way to do it is to have a qualified engineer look over the equipment installation and ensure that it meets the requirements for the install (meaning things like the electrical connections are correct, the equipment works when turned on, etc.)  Not the best of circumstances but considering you have a decade of experience with the equipment already it might be acceptable.

    Regarding the OQ that is actually a little easier.  Since the OQ is done only after installation you could simply either purchase the validation package or documentation from the vendor and run the validation yourselves, or you could have the vendor (if they are still around) come in and run it for you (for a fee) and report out the results, or you could develop your own OQ based on your own particular requirements/needs if either the vendor is no longer in existence or if they don't have any specific documentation for this equipment version any longer.  Again, with a  decade of experience in hand you should be able to determine what would work best for the company and still maintain a compliant state.

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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  • 3.  RE: IQ/OQ on existing equipment

    Posted 23-Aug-2017 10:22
    This is not as uncommon as you might think, and there are a variety of ways to do it.

    First - pretend it is a new piece of equipment and process, with the exception of using your current knowledge for process characterization.
    Second - do a combination of retrospective and prospective validations. For instance, you may have an installation report somewhere that can serve as the basis of IQ. If not, potentially your deviation/maintenance information can go a long way toward it, when pulled together with a requirements list. For OQ, do you currently have any data on how well the process operates at the extremes of your process variables? If so, you can potentially pull this together in support of your OQ. Also, process characterization data could be pulled together to identify the "worst cases" for a limited OQ.

    For PQ, it is possible that you collect enough control data during your process to put together a retrospective PQ - I'd suggest first determining what data you have available that potentially can be used.

    g-

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    Ginger Glaser RAC
    Vice-President, Engineering
    MN
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