Knowledge from the field of GMP compliant calibration
The knowledge area GMP compliant calibration deals with calibration in pharmaceutical and medical technology areas and explains the essential differences to conventional calibration.
Here you will find answers to the following questions:
How does a GMP compliant calibration differ from a conventional one?
The difference is in the documentation (before and after). In a "normal" calibration, the technician does it to the best of his knowledge. He notes the values and issues a certificate.
A calibration is GMP compliant if it is accompanied by a pre-established work instruction, defined measurement uncertainty limits and other appropriately defined specifications. Finally, the technician issues a standardized GMP compliant certificate that is also defined.
Calibration in GMP-regulated areas