Additional Calibration Needed for NIST Pre-calibrated Temperature Monitor?

[biggwaltz1]

Good day. I am am in new QA role. The company has a general procedure for monitoring a storage area for retaining samples at the office. I think per GMPs (specifically 21 CFR 211.68a) the temperature needs to be measured by an instrument that is calibrated. The samples will be "held" (not warehoused but in a cabinet), and never be for commercial sale (therefore no patient impact). I suggested using an NIST pre-calibrated thermometer for the periodic measurements (i.e. annually). Do you believe the NIST pre-calibration will be sufficient moving forward, or should there be a temperature measurement subject to periodic re-calibration? And if not, how do I justify? Any help/advice is appreciated.

 

[Ed Panek]

Based on risk we use wireless 21 CFR part 11 compliant monitors in production and warehouse areas on a 2 year cal interval that we set email alerts for above or below certain temps and RH. It depends on how your device reacts to environmental changes and the risk if it does. For something like a vaccine it could hurt someone. In the event of some adhesive, the risk is it is maybe 10% less sticky. Use risk in your decision and budget.

 

[dwperron]

21 CFR 58.63 states "The written standard operating procedures required under § 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, "
Based on risk to processes or products you need to determine a schedule for recalibration of your thermometer, because they will vary with time.

 

[biggwaltz1]

Thanks for the responses! This has been most helpful.