Instrument calibration in GMP: a practical guide to metrological management
How to manage calibration in GMP: critical instruments, traceability, intervals, Out of Tolerance, audit trail and data integrity.
Resource cluster
GMP calibration guides
Management of instrument calibration, intervals, Out of Tolerance and data integrity.
Pillar 7 min ACCREDIA-accredited calibration and on-site calibration in pharma
What ACCREDIA-accredited calibration means, when a LAT centre is needed and how on-site calibration of critical instrumentation works in a GMP site, with documented traceability.
7 min Data integrity in calibration records: ALCOA+ and Annex 11 in practice
Calibration records are GxP data in every respect and must comply with the ALCOA+ principles. What this means in practice for those managing the metrology of a GMP site, with or without digital support.
6 min Calibration interval: how to define it, justify it and let it evolve
Criteria for setting and reviewing calibration intervals: criticality, drift, use conditions, history, OOT events and documented justification.
7 min Out of Tolerance: how to manage the impact on batches already released
A critical instrument out of tolerance at the periodic calibration is not just an instrument problem: it is a potential retroactive deviation. How to conduct the impact assessment according to GMP.
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