SUPPLIER EVIDENCE · 2026-10-06
Supplier CoA request template: what to ask for and check
A Certificate of Analysis should answer a question about an identified material and batch. Before comparing a result with a requirement, establish what was sampled, which delivery it represents and how the laboratory reported the measurement.
Collect evidence, not just files.
Request the lot and specification version, results, units, methods and issuing laboratory. ‘PASS’ alone does not reveal what was measured. Record missing information as a gap rather than filling it with an assumed value or a positive compliance finding.
Start with the question the document must answer
A specification sets expected properties and acceptance criteria. A CoA reports information about a tested sample or batch. A signed sheet containing only ranges may be a specification rather than an analysis result. Raw material and finished supplement are also different objects: evidence about one does not automatically establish the identity, composition or contaminants of the other.
Connect the document to the physical delivery first: outer-pack identification, lot number, material code and supplier. Where a distributor renumbers the manufacturer's lot, request documented mapping. Different numbers do not prove fraud, but they leave batch identity unresolved. A perfectly formatted result is not useful for your batch decision until that relationship is established and recorded.
The right test panel, sampling approach, method and acceptance criterion depend on the material and use. This checklist identifies questions; it does not set universal legal limits. If a report uses an older method version or an unspecified analytical scope, ask the supplier or laboratory to clarify before drawing a conclusion. Keep a supplier's summary distinct from the original laboratory report.
What to check and how to record a gap
QA recommendations to adapt to the material and intended decision. Not a universal statutory list or an automatic compliance test.
| Check | Request evidence | Common gap |
|---|---|---|
| Material and form | Name, code, chemical form or botanical species/part and preparation identity. | The report describes a different form, extract or carrier from the delivered material. |
| Lot and sample | Batch number, sample identifier, delivery mapping, sampling and testing dates. | A specimen CoA is supplied, or the sample's origin cannot be reconstructed. |
| Result and unit | Measured value or meaningful qualitative result, units and calculation basis. | ‘Complies’ hides the result; its unit does not match the acceptance criterion. |
| Method and sensitivity | Analyte-specific method, relevant LOD/LOQ and explanation of below-limit reporting. | ND is treated as zero despite unknown detection capability or reporting convention. |
| Specification and criterion | Revision, criterion source and distinction between legal and contractual requirements. | The result is checked against an old specification or another product category's limit. |
| Laboratory and scope | Issuer, report number and relevant declared accreditation scope where needed. | An accreditation logo is treated as covering every analytical method on the sheet. |
| Authenticity and corrections | Original report, issuer-confirmation route and retained corrected-version history. | An edited spreadsheet of unknown origin replaces the original or erases a prior result. |
A plausible file, an unconfirmed scope
Working example: a contaminant result is reported as ‘ND’, without a method or LOQ. Do not enter 0 or conclude PASS. Record ‘method sensitivity not established’, request the missing information and identify the applicable criterion. Separately check whether the sample was raw material, a blend or a finished capsule. Even a correctly reported number does not resolve a sample-scope mismatch.
Fictional example, not an assessment of a real supplier. Missing information, mismatch and a negative result are different findings.
A ready-to-adapt supplier request
Select and copy the text. Fill only the relevant fields and agree a deadline; this page does not send messages or collect documents.
Received does not mean verified
- Define the testing purpose, material, delivery, lot and specification revision. Do not begin with a random online limit.
- Request the document and missing fields. Distinguish the original laboratory report from a supplier's result summary.
- Compare sample identity, dates and units. Record unconfirmed mappings or conversions for clarification before interpretation.
- Assess the method against the relevant criterion. Missing sensitivity or test scope cannot become a positive review result.
- Retain originals and corrections. An authorised operational person decides further testing or batch disposition after review; a request template cannot release stock.
Common questions
Does ND mean the substance is absent?
Do not interpret it as zero. Establish the report's convention, method and detection or quantification limits. Comparison with a criterion needs that information and the correct unit, not the abbreviation alone.
How long is a CoA valid?
Do not apply one expiry period to every report. Results concern a sample and test date. Their relevance to current stock, storage conditions and intended use needs assessment; the date printed on the report cannot replace it.
Can a supplier CoA replace our own testing?
Not automatically. The applicable regime, qualification programme and controls matter. The US provision illustrates conditional reliance; it does not answer the legal question for an EU product.
Review the next evidence type
Explore the supplier-evidence preview
An existing preview: no upload of private documents, persistence or issuer authentication. It is not an operational Supplier Evidence Inbox or supplier/product approval.
Check the original source
eCFR / US · 21 CFR 111.75US requirement, not EU law · original: EN · 2026-10-06 ↗Editorial source reading: 2026-10-06. Not a refresh of active rules. Complete EU operative texts were not verified in this review; institutional sources and programmes have their stated scope. Educational material, not an assessment of a particular SKU, lot or supplier.