Audit and batch records
Complete, audit-ready batch records under 21 CFR Part 111.
HBM maintains a complete batch record for every production run under 21 CFR Part 111, audited annually by a third party. Each record covers identity testing, weights, in-process checks, deviations, and personnel, and is retained and available for customer and regulatory audit.
What a batch record covers
Every batch record documents raw-material identity testing, component weights, in-process quality checks, equipment used, deviations and their resolution, and the personnel who performed each step. It is the paper trail that proves what went into a product and how it was made.
Third-party audited
HBM operates under cGMP (21 CFR Part 111) and is audited annually by an independent third party, alongside NSF and the brand audits our customers run. Records are organized so an auditor, or your QA team, can trace any lot end to end.
| Standard | 21 CFR Part 111 (cGMP) |
|---|---|
| Audited | Annually, third party |
| Covers | Identity, weights, deviations, personnel |
| Availability | Customer and regulatory audit |
FAQ
Are batch records available to customers?
Yes. Batch records are retained and made available for customer and regulatory audit.
What standard governs HBM batch records?
21 CFR Part 111 (cGMP for dietary supplements), audited annually by a third party.
Can a single lot be traced end to end?
Yes. Records tie raw-material identity, in-process checks, and finished-product data to each lot.
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