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GLP Requirements to Temperature Map Equipment

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  • Anon
    15/11/2013 16:18
    My company works to both GLP and GMP requirements. We currently validate fridges, freezers and incubators in the same manner i.e. they are temperature mapped every 1 or 2 years. I think this is excessive for GLP areas and would like to reduce this significantly. What do other GLP sites do? We propose to temperature map GLP equipment once when it is initially validated and to ensure an Independent Monitoring Probe (IMS) is located in the “worst case location” in the equipment. Then on an annual basis review the IMS data to see if the data is moving to the upper or lower limits of the equipment, signing off the equipment for another year if the data demonstrates it is under control. Would this approach be acceptable for GLP equipment?
  • Anon
    15/11/2013 17:21
    Yes
  • Anon
    02/12/2013 10:32
    The MHRA GMP inspectors' guidance on cold storage is worth checking: http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con007569.pdf My experience is that GMP requirements in this area are more rigorous than GLP.
  • RQA GLP Committee
    03/12/2013 21:00
    Response following discussion at a recent GLP Committee Meeting Temperature mapping is recommended at equipment validation and in very large environmentally controlled areas. For GLP purposes it not usually repeated as often as every year, although records generated need to be reviewed much more frequently.
  • Eileen Flynn
    11/09/2019 20:00
    For an initial GLP PQ on a freezer - is there a minimum number of thermocouples that should be used and a minimum time for data logging? I've seen 10 thermocouples for 24 hours - but I was recently at a site that used one probe per shelf for 3 hours - empty only. No 60% full or open door test. For GMP that wouldn't fly - but for GLP is that acceptable? Thanks!!
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