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Certificate of analysis (COA)

A certificate of analysis, or COA, is a lot-specific document summarizing the test results and release criteria applied to a tissue or biologic product before it was released for distribution. It is the primary record a buyer can use to see what a specific lot was tested for and what the results were.

A COA is tied to a single lot, identified by its lot number, rather than to a product line generally. Confirm with the supplier what the COA for a given product lists; it may include tests performed, such as sterility testing, and other release criteria depending on the supplier's internal specifications. Because requirements and formats vary by product type and by supplier, a COA for one product line is not a template for reading another.

Requesting a COA before an order ships, and matching the lot number on the COA to the lot number on the product received, is a basic way for a clinic to confirm that the documentation it reviewed corresponds to the product it actually has in inventory. A COA that cannot be matched to a physical lot number is of limited use for recordkeeping.

A COA is a records document, not a marketing claim. It describes what was tested and found for that lot; it does not describe what the product does clinically, and a buyer should not read test results, such as a particle count or protein panel, as a statement about intended use or outcome.

A matched, lot-specific COA is the basic documentation a clinic needs to support its own quality and recordkeeping obligations for any tissue or biologic product it stocks.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR
  2. Colony forming potential and protein composition of commercial umbilical cord allograft products ↗Am J Sports Med