When a product is initially approved, the buyer is effectively approving a defined combination of product, process and packaging conditions. Significant changes to those conditions should be assessed for customer impact.

Which changes can be material?

Source, granulation process, additive use, packaging material, label, production location or analytical method can affect an approved specification.

Define notification timing

Repeat supply agreements can identify which changes require advance notification and how much notice is expected.

Decide whether requalification is needed

If product performance may change, a new reference sample, COA or process trial can be appropriate.

Maintain revision history

Old and new specifications, artwork and packaging revisions should be retained with dates and approvals.

Buyer checklist

  • Change type
  • Affected SKU
  • Notification date
  • New specification
  • Sample requirement
  • COA/analysis requirement
  • Customer approval

Related guides

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