GLP Requirements to Temperature Map Equipment
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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?
RQA GLP Committee
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.
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?
RQA GLP Committee
You need to establish that the freezer is fit for purpose. The number of points tested, how and when, is not defined in the regulations, but if this freezer is critical to some or all of your studies then you need to be confident that whatever is in there is preserved adequately.
Consider the risks to your study if you did not do the 60% full test or open door test and adjust your PQ accordingly.
It also depends on the size of the freezer – chest vs. walk-in or box. There is an expectation from the MHRA for more freezer mapping for the larger walk in freezers.