The new version of GMP Article 86 requires: "Equipment and instruments used for drug production or inspection shall have a usage log, which includes usage, cleaning, and maintenance."
Protection and maintenance status, as well as date, time, name, specifications, and batch number of drugs produced and inspected.
According to the record content specified in the Instrument (Equipment) Usage Log, its functions can be reflected in at least the following aspects:
One is the traceability function.
This is also the most important and primary function. Is there strict adherence to relevant operating procedures during drug production? Does it comply with the prescribed production process flow? Is there any cutting corners or cutting corners
For, Wait, although it is reflected in the batch records, it can be mutually verified with the usage records of electronic balance instruments (equipment), which is an effective measure to prevent illegal operations.
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