We are reviewing our qualification and control strategy for calibration and thermal validation reference equipment in a pharmaceutical manufacturing facility.
We use equipment such as reference thermometers, pressure gauge, automatic pressure calibrator, thermal baths/dry blocks, pressure calibrators, tachometers, anemometer, Humidity chamber, ellab validation system, standard weights, and reference data loggers/sensors for calibration and thermal validation activities.
These instruments are used as reference/calibration standards and are not directly involved in manufacturing or product processing.
Our current practice is to control these instruments through calibration with traceability to national/international standards, calibration certificates, identification/status labeling, defined calibration intervals.
We would like to understand the EU GMP expectation regarding qualification of such reference equipment:
Is URS, DQ, IQ, OQ and PQ required for calibration/thermal validation reference standards?
If full qualification is not universally required, can the qualification approach be risk-based, considering the intended use, criticality, accuracy, traceability and impact on GMP decisions?
For equipment such as reference thermometers, pressure gauge, automatic pressure calibrator, thermal baths/dry blocks, pressure calibrators, tachometers, anemometer, Humidity chamber, ellab validation system, standard weights, and reference data loggers/sensors what level of qualification would normally be expected during an EU GMP inspection?
Can appropriate calibration, traceability, acceptance criteria, uncertainty, verification and documented risk assessment provide sufficient control instead of full IQ/OQ/PQ for certain reference standards?
Are there any specific requirements or inspection expectations under EU GMP Annex 15, EU GMP Chapter 3/4, PIC/S or ISO/IEC 17025 that we should consider?
We would particularly appreciate feedback from EU GMP inspectors, auditors, validation/qualification professionals or experienced pharmaceutical calibration specialists, preferably with the relevant guideline/section or practical inspection experience.
Thank you.