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Northfield Manufacturing

Electronic Batch Manufacturing Record (eBMR)

21 CFR 211.188 — batch production and control record

Sample report · eBMR WO-0142 v3 · Lot P-0142

What the full report contains

  1. Batch identity
  2. Materials dispensed (planned vs actual)
  3. Weighing log WGL-0142 (complete — all dispense weighings)
  4. Charge log CHL-0142 (extract reference — every manual addition second-person verified per SOP-PRD-014)
  5. Equipment checks
  6. Critical process parameters
  7. Yield and mass reconciliation
  8. Deviation
  9. Release tests
  10. Signatures
  11. Event sequence and review evidence
  12. Batch evidence review checklist
  13. How this record is built

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