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  1. #1
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    Default PQ for Tablet Coating machine

    My company has Old Japanese Coating machine.

    and I'm gonna do the PQ for tabelt coating machine.

    The instruments that the machine has, are analog temp. indicator(Supply and exhaust), RPM meter, mist checker(for air flow), flow meter(for coating liquid).

    Supply temp. can be controlled ,but the Exhaust temp. is not controled(just for monitoring.)



    Which items are subject to the PQ?

    DO I have to check Temp, RPM, airflow rate, like OQ?

    Or Do I have to focus on the product's physical state? Thickness something like that?

    If it does, which one is that?

    Please, Tell me what you know.

    Thank you.
    Last edited by Jae il, Lee; 03-24-2008 at 12:15 AM.

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    Last edited by Jae il, Lee; 03-24-2008 at 12:15 AM.
     

  3. #2
    Validation Analyst
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    Default

    PQ would generally focus on the product parameters (coating uniformity, sticking, picking, etc),but it is common to redo certain OQ elements to observe the impact that the tablet bed has on the mechanical parameters if the OQ tests had been done in an empty chamber. As a minimum I would check the speed setting, inlet and outlet temperature (info), filter shakers perhaps, not much more. The sprayers performance would be confirmed by the physical inspection of the coated product.

  4. #3
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    Smile performance Qualification

    Hi ,
    my self pankaj and I am also new to this field perhaps folowing lines may help you
    During performanace qualification following things should be noticed :
    In case of new facility it can be done by making use of Dummy batches
    and folowing parameters can be taken ;
    physical parameter of the machine
    -Operatinal Timing
    -Operational Range (maximum and minimum )

    Analytical parameters
    -Analytical parameters (Assay ,Content uniformity etc.)

    by all these we will try to conclude that our machine is performing well as all the analytical parameters are quite with in the limit hence the particular machine performance is qualified .

    hope fully it will solve your problem a little bit
    Pankaj Kr.Sharma
    Quality Assurance[color="DarkRed"]
    Himachal Pradesh(Baddi )

  5. #4
    Validation Expert
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    Default PQ for Tablet Coating machine

    Good day all
    There must be a whole chain of regulatory required documents in place before you even contemplate PQ.

    First, there should be a Validation Plan (VP) (it can be quite a simple plan). The plan must give managements reason for using the machine. Along with the use it will be validated for, and authority for all required validation methods and actions. It must further delegate responsibilities for all the validation actions, and set the scope of these actions. At this stage a Validation Risk Assessment (VRA) should be used in setting the scope. Once these high level decisions are made the VP must be signed off as a working document that has now set the company’s validation requirements for this piece of equipment.

    Protocol authors can now write the IQ – OQ – P1Q – P2Q documents, in accordance with the company’s approved practices and procedures. Whether P1Q – P2Q are both required depends on your VP. A machine can have a range of settings and functions, perhaps you only want to validate one process – perhaps you want to validate the entire functionality - perhaps your product is too expensive to waste and you intend to use a placebo to validate the actual process settings. (P1Q - Performance Qualification, P2Q – Process Qualification. These acronyms are used by many in the industry to clarify and distinguish between the the use of of these two PQ's)

    There are consultants that would argue, that you must start at User Requirements Specification level (URS), since your P2Q is based on verifying that the URS has been satisfied. This is where the justification for your validation approach must be documented in the VP, without the end user documenting what the equipment is required to do (the exact measurable process and specifications), how can you scope a P2Q?

    A P2Q that is carried out using equipment that has not been subjected to the above procedure (or a very near justified equivalent) has no standing and any product subsequently produces would be considered by the regulators as adultered.

    If you wish to go to: -
    http://www.validation-online.net/val...line-blog.html
    you will find diagrams indicating this document sequencing and highlighting the cross references. These can be freely copied off the site.

    Alex Kennedy
    www.validation-online.net

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