Formulation Specifications and Batch Control
The approved formula, ingredient, weighing, sequence and reconciliation controls that ensure each production batch matches its specification.
The controlled specification defines product identity, raw materials, ingredient strengths, tolerances, process steps, endpoints, packaging and storage. Production copies should be versioned and authorised.
Each lot is checked against the approved name, supplier, strength and allergen or additive status. Similar-looking curing premixes or functional ingredients are not substituted without review.
Ingredients are weighed with suitable equipment, independently checked where risk warrants, and issued to the correct batch. Tare, unit and decimal errors are prevented through the record design.
Order of addition, temperatures, mixing time, hold time and equipment load are recorded where they influence performance. Deviations are visible rather than hidden in narrative notes.
Actual ingredient totals, rework, yield and package counts reconcile to the batch. Lot codes connect raw materials, process records, tests and finished product disposition.
Formula changes, supplier changes and deviations receive technical review before release. A successful previous batch is not evidence that an undocumented change is acceptable.
Related in the Codex
References
- https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf
- https://www.fsis.usda.gov/policy/fsis-directives/7120.1
- https://www.nist.gov/calibrations/traceability