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Departmental Roles in equipment qualification

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Jennie, Jan 19, 2016.

  1. Jennie

    Jennie Member

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    Hello, in practice what is typically the role of QAQC in equipment qualification? What are the other departmental roles? It's my understanding the QAQC role is to make sure that the testing is appropriate, adequate, and complete. During the protocol phase QAQC works with engineering and production to design tests. During the execution phase QAQC verifies that the testing was done per the protocol and all testing was complete and meets specs. Is this correct? Which department actually "owns" the validation? Thanks for your input.
     
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  2. Candi1024

    Candi1024 Well-Known Member

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    In our company, either production or engineering could own the validation. Our quality review works as you described.
     
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  3. Vthouta

    Vthouta Member

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    In our company, the Engineering or the relevant test group who designed the test owns qualification, just like the process owner. We do similar activities as you mentioned but QAQC doesn't own the qualification. For example, a new equipment is brought into the plant, the process owner creates the qualification and reviews with quality to meet any requirements that could include ISO/regulatory, then followed by reviewing the execution and signing off to make sure they meet all the criteria listed on the protocol.
     
  4. Metrologist

    Metrologist New Member

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    This may be off topic but if anyone has any suggestions it would be very appreciated.
    Currently our CO2 incubators are qualified at 37 Degrees and 5% CO2. continuous change by the user is now required.
    what is required to maintain control and still allow the processes to to continue?
    An example of change is to set the incubator to 36 Degrees 8% followed by 32.5 degrees at 0% and 38 degrees with 2% CO2 . Several other points may also be required. Currently we issue a change Control and perform calibrations and full qualifications(empty ,loaded, open door, power failure) for each set point change.
    This seems extreme and causes up to a month of process halt until the change control and the new qualification documents are signed by QA. in my 30 years of performing these tests we have not had a single failure that was temperature or CO2 related. This causes my question of why do we do this?
    There must be a logical and more cost effective way to change a set point of an incubator and still remain compliant. I welcome any suggestions as i cannot find any detailed regulations requiring these actions.
     
  5. Candi1024

    Candi1024 Well-Known Member

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    I would qualify them over a range, very similar to the way you calibrate over a range.
     

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