Equipment calibration
A documented calibration program across the floor.
HBM runs a documented equipment calibration program as part of cGMP under 21 CFR Part 111. Scales, depositors, mixing vessels, and packaging equipment are calibrated on a defined schedule with records retained, so measurements stay accurate and traceable batch to batch.
What gets calibrated
Calibration covers the equipment that affects product quality and accuracy, including scales and balances, the continuous gummy depositors, jacketed mixing vessels, and packaging and filling lines. Each is checked against a schedule and tolerance.
Records and traceability
Calibration is documented and retained alongside batch records, so any measurement on a production run can be tied back to equipment that was in calibration at the time, part of HBM’s audit-ready quality system.
| Program | Scheduled, documented calibration |
|---|---|
| Covers | Scales, depositors, vessels, packaging |
| Standard | 21 CFR Part 111 (cGMP) |
| Records | Retained, audit-ready |
FAQ
Does HBM calibrate its equipment on a schedule?
Yes. Calibration follows a defined schedule with retained records, under cGMP.
Is calibration documented for audits?
Yes. Calibration records are retained and available alongside batch records.
What equipment is calibrated?
Scales and balances, depositors, mixing vessels, and packaging/filling lines.
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