BOD IncubtorIQ/OQ - Qualification

GOOD DOCUMENTATION PRACTICE (GDocP) OQ (OPERATIONAL QUALIFICATION)
1

Dear Sir/ Madam,

We have procured BOD Incubator one year back and the warranty of the Instument and validity of the certificates for PT100 sensor, Temperature controller & thermostat got expired. we started IQ, OQ after one year and supplier told that calibration of the sensors & controller can be performed during the start of PQ study, but we disagreed for that because there is a test called temperature stabilisation study & Thermostat safety cutoff study. PL suggest is it acceptable?.

2

This is not acceptable. It is better to calibrate all the temperature sensors and controller on current date and then proceed for qualification activity.

3

You should qualify and calibrate all temperature sensors before you perform a PQ phase.
You can add a checklist before PQ phase and attach to PQ document. This list should let you know about the date and details regarding calibration of the thermostats or sensors.

4

Dear Sir, Already we completed IQ, OQ, but yet to start PQ, before PQ we are calibrating the sensors.is it OK.

5

Thanks sir