Protocol – Shelf-Life Validation
Shelf-life validation is what stands behind the date on the pack – micro, sensory, and physico-chemical testing through the full life plus a safety margin, under realistic storage.
Fill this in as you go, not from memory at the end of the shift – records reconstructed later are where the errors creep in. Replace [bracketed] guidance with your site’s detail.
1. Document control
| Field | Details |
|---|---|
| Document title | Protocol – Shelf-Life Validation |
| Document no. | [QA-FORM-045] |
| Version | [1.0] |
| Effective date | [YYYY-MM-DD] |
| Prepared by | [Name / Title / Date] |
| Approved by | [Name / Title / Date] |
| Review date | [YYYY-MM-DD] |
1. Study design
- Product: | Proposed shelf life: days
- Storage conditions tested: (include abuse condition)
- Pathogens of concern:
- Tests: [micro / sensory / pH / aw – schedule]
- Acceptance criteria:
- Challenge testing required? [Y/N – protocol ref]
2. Results summary
| Test point (day) | Micro results | Sensory results | pH / aw | Pass / Fail |
|---|---|---|---|---|
| [0] | ||||
| [mid-life] | ||||
| [end of life] | ||||
| [end of life + margin] |
3. Conclusion
Set the shelf life with a margin inside the validated life – the study proves what’s safe, the date mark should sit comfortably short of it. And re-validate when the recipe, process, or packaging changes.
- Validated shelf life: days
- Date mark to be applied: days (with margin)
- Storage instructions for label:
- Overall result: [Pass / Fail]
- Approved by: [Name / signature / date]
Approval and control
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by | [Name] | [Signature] | [Date] |
| Reviewed by (QA) | [Name] | [Signature] | [Date] |
| Approved by | [Name] | [Signature] | [Date] |
Keep completed forms for Retain for life of the product plus [3 years]. at [defined location] – and make sure someone besides you knows where that is.