Article 86 of the new version of GMP requires: "equipment and instruments used for drug production or inspection shall have use logs, including use, cleaning and maintenance
Care and maintenance, date, time, name, specification and batch number of drugs produced and inspected, etc.
According to the records specified in the instrument (equipment) use log, its function can be reflected at least in the following aspects:
One is the traceability function.
This is also the most important and main function. Are the relevant operating procedures strictly implemented in the process of drug production? Does it comply with the specified production process? Is there a line of shoddy work and materials
For, And so on, which is certainly reflected in the batch records, but it is an effective measure to prevent illegal operations if it is mutually confirmed with the use records of electronic balance instruments (equipment).
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