Certificate of Analysis Review Log

Inspection template for logging receipt and review of supplier Certificates of Analysis (COAs) against incoming material specifications, and documenting lot release only after COA acceptance.

Receiving and Traceability

• Supplier name matches approved source
  Confirm the COA was issued by the approved supplier or authorized manufacturer listed on the approved supplier list.
• Material name and item code match receiving record
  Verify the COA material description, item code, and purchase/receiving record identify the same material.
• Lot or batch number recorded
  Record the supplier lot or batch number shown on the COA and confirm it matches the received container labeling.
• Quantity received documented
  Enter the quantity received for the lot being reviewed.

COA Receipt and Document Control

• COA received before lot release
  Verify the lot has not been released to production, use, or storage for use prior to COA review completion.
• COA document is legible and complete
  Check that the COA includes all pages, readable results, and no missing or obscured fields.
• COA issue date recorded
  Capture the date the COA was issued by the supplier.
• COA revision or version matches approved requirement
  Confirm the COA format, revision, or version is acceptable per the current quality agreement or SOP.

Specification Review Against COA

• Identity test meets specification
  Verify the COA identity result meets the approved material specification.
• Critical quality attributes meet specification
  Confirm all critical or release-defining attributes listed on the COA meet the approved acceptance criteria.
• Numeric test results recorded
  Document any key COA test values reviewed against specification limits, including units where applicable.
• No unexplained out-of-specification results
  Confirm there are no OOS, OOT, or other unexplained discrepancies on the COA.
• COA results align with material specification
  Verify the COA results are within all required acceptance limits for the material.

Exceptions, Discrepancies, and Non-Conformance

• Discrepancies identified and documented
  Document any mismatch between the COA, receiving record, and approved specification.
• Material placed on hold or quarantined if required
  Confirm non-conforming or pending-review material is segregated and not released for use.
• Corrective action or supplier follow-up initiated
  Record whether a supplier complaint, deviation, or corrective action request was opened.
• Non-conformance details
  Describe the deficiency, affected lot, and any immediate containment action taken.

Disposition and Release Authorization

• Lot disposition selected
  Select the final disposition for the lot after COA review.
• COA accepted prior to release
  Confirm the lot was released only after COA acceptance and required review completion.
• Reviewer comments
  Add any final notes regarding acceptance rationale, exceptions, or follow-up actions.
• Reviewer signature
  Signature of the person approving the COA review and lot disposition.