As part of Qualification, temperature mapping is completed. Is it necessary to perform the same on periodic basis i.e. annually or else? Is there any regulatory requirement on such issues?
Thanks in advance
Satya
As per good Engg and Maitenance practices you can map the temperature every 6 months once.
As per good Manufacturing practices you can map tempertaure every 8 months to 12 months once.
The answer to your question is, not surprisingly, it depends. For systems like autoclaves and lyophilizers that are high criticality or have sterility implications, it is typical and recommended to perform studies on an annual basis. I don’t believe that’s encoded in the regulations, but it is a regulator expectation. For units that do not have sterility implications, there is no requirement to remap on a periodic basis, assuming that you’re following the appropriate change control procedures and are continuously monitoring and alarming the conditions within the chamber with a qualified monitoring system. In such units, remapping should be event-based, and should probably occur after moving the unit, refrigerant recharge, or refrigeration system repair, to name a few. Some companies elect to do a time-based remap for quality reasons, but in my experience, it is not necessary if you have a change control procedure that is being followed and a monitoring system in place.