In Annex 15 of EU GMP, the below is stated:
Section 5.22. Process validation protocols should include, but are not limited to the following:
vi. List of the equipment/facilities to be used (including measuring/monitoring/recording equipment) together with the calibration status
Could you please share your opinion on this matter? How do you interpret this info?
Does it mean that the qualification & calibration status of the equipment and instruments respectively should be checked prior to the production of validation batches by Process Validation Team? OR
Does this mean the qualification and calibration status of all potential equipment and instruments respectively should be checked for a product by Process Validation Team?
And is it adequate to check if the machine or instrument is qualified or calibrated for the first time? Is it required to check for the re-qualification and re-calibration status?
Many thanks in advance,