Supplier evaluation rubric
The six weighted criteria, the anchored zero-to-five scale, and what the resulting score does and does not mean.
The Institute assesses documentation, not product. It has purchased nothing, tested nothing and inspected nothing. Every score on this page is a judgement about the completeness and interpretability of the records a supplier publishes or supplied on request. A high score means that a supplier documents its material well. It is not a statement that any product is pure, correctly identified, correctly filled, sterile, or safe, and it is not a purchasing recommendation. The Institute makes no purchasing recommendations.
§1What the rubric measures
The rubric measures the completeness and interpretability of the records a supplier publishes or supplies on request. It does not measure product quality, and the Institute has not measured product quality for any supplier in its set.
The relationship between documentation quality and product quality is plausible and unmeasured. A supplier that reports a purity figure with its method, a peptide content against a named standard, a water determination and a counter-ion determination has supplied enough information for a purchaser to know what they received. A supplier that reports a bare purity percentage has not. That difference is real and it is the difference this rubric measures. Whether it predicts what is in the vial is a separate question that would require independent testing to answer, and the Institute does not perform independent testing.
§2The six criteria
Table 1. The six criteria and their weights. Weights sum to 100.
| Criterion | Weight, % | What it assesses |
|---|---|---|
| Certificate-of-analysis completeness | 25 | Assessed against the Institute's COA minimum data standard (CEI-MS-14). Full marks require identity by two orthogonal methods, purity by a stability-indicating chromatographic method with the method stated, peptide content, water content, counter-ion identity and content, and batch traceability. |
| Independent third-party testing record | 25 | Frequency, breadth and verifiability of testing by a laboratory independent of the supplier. Reports must be attributable to a named laboratory and a named batch. |
| Identity confirmation practice | 15 | Whether identity is confirmed by an orthogonal method rather than inferred from a single chromatographic retention time, and whether investigational compounds with contested sequences are addressed. |
| Documentation transparency and consistency | 15 | Consistency between published figures, catalogue claims and independent results; willingness to correct; disclosure of what isn't tested. |
| Storage, packaging and cold-chain evidence | 10 | Evidence that storage and shipment conditions are controlled and documented, and that light- and oxidation-sensitive compounds are handled accordingly. |
| Responsiveness to documented enquiry | 10 | Response to the Institute's written enquiries regarding batch documentation, method details and discrepancies. Recorded in each dossier's correspondence log. |
§2.1Certificate-of-analysis completeness
Assessed against the Institute's COA minimum data standard (CEI-MS-14). Full marks require identity by two orthogonal methods, purity by a stability-indicating chromatographic method with the method stated, peptide content, water content, counter-ion identity and content, and batch traceability.
Table 2. Anchors for certificate-of-analysis completeness.
| Point | Anchor |
|---|---|
| 0 | No certificate, or a certificate with no method information |
| 1 | Purity percentage only, no method, no batch link |
| 2 | Purity with method named; no content or counter-ion |
| 3 | Purity, method and mass-spectrometric identity; content absent |
| 4 | All critical fields present; one or two recommended fields absent |
| 5 | Every critical and recommended field present with traceable batch linkage |
§2.2Independent third-party testing record
Frequency, breadth and verifiability of testing by a laboratory independent of the supplier. Reports must be attributable to a named laboratory and a named batch.
Table 3. Anchors for independent third-party testing record.
| Point | Anchor |
|---|---|
| 0 | No independent testing published |
| 1 | Isolated reports, batch not identified |
| 2 | Occasional reports for a small part of the catalogue |
| 3 | Regular reports across a substantial part of the catalogue |
| 4 | Systematic per-batch reporting for the principal product lines |
| 5 | Systematic per-batch reporting across the catalogue with verifiable laboratory attribution |
§2.3Identity confirmation practice
Whether identity is confirmed by an orthogonal method rather than inferred from a single chromatographic retention time, and whether investigational compounds with contested sequences are addressed.
Table 4. Anchors for identity confirmation practice.
| Point | Anchor |
|---|---|
| 0 | No identity method reported |
| 1 | Retention time only |
| 2 | Mass spectrometry reported without resolution or expected-mass statement |
| 3 | Mass spectrometry with expected mass stated |
| 4 | High-resolution mass spectrometry with deconvoluted average mass |
| 5 | Orthogonal identity with sequence confirmation for compounds where the sequence is contested |
§2.4Documentation transparency and consistency
Consistency between published figures, catalogue claims and independent results; willingness to correct; disclosure of what isn't tested.
Table 5. Anchors for documentation transparency and consistency.
| Point | Anchor |
|---|---|
| 0 | Claims contradicted by independent data with no correction |
| 1 | Material inconsistencies unresolved |
| 2 | Minor inconsistencies; no stated correction process |
| 3 | Consistent documentation; limitations not disclosed |
| 4 | Consistent documentation with limitations acknowledged |
| 5 | Consistent documentation, limitations disclosed, and corrections issued when identified |
§2.5Storage, packaging and cold-chain evidence
Evidence that storage and shipment conditions are controlled and documented, and that light- and oxidation-sensitive compounds are handled accordingly.
Table 6. Anchors for storage, packaging and cold-chain evidence.
| Point | Anchor |
|---|---|
| 0 | No information |
| 1 | Generic statements only |
| 2 | Storage conditions stated; shipment uncontrolled |
| 3 | Cold-chain used for sensitive lines |
| 4 | Cold-chain documented with excursion handling |
| 5 | Documented conditions with compound-specific handling including light protection |
§2.6Responsiveness to documented enquiry
Response to the Institute's written enquiries regarding batch documentation, method details and discrepancies. Recorded in each dossier's correspondence log.
Table 7. Anchors for responsiveness to documented enquiry.
| Point | Anchor |
|---|---|
| 0 | No response to any enquiry |
| 1 | Response without substantive content |
| 2 | Partial response after repeated enquiry |
| 3 | Substantive response within 30 days |
| 4 | Substantive response within 14 days with documents supplied |
| 5 | Substantive response within 7 days with documents and method details supplied |
§3The three verification states
Table 8. The three states used on every dossier. The distinction between the second and third is the substance of the assessment.
| State | Meaning |
|---|---|
| Verified | Documentation supporting the claim was examined by the Institute. Verification is of documentation and never of product. |
| Not verified | The Institute looked for supporting documentation and did not find it. A supplier may hold data it does not publish, and the assessment cannot distinguish an absent determination from an unpublished one. |
| Not assessed | The Institute did not examine this attribute. Carries no implication about the attribute and is recorded so that it can be told apart from a failed verification. |
§4What no score establishes
The rubric, its weights and its anchors were settled through a public comment period and revised through a second consultation on dossier format. Both dispositions are published in full, including the submissions the Institute did not accept.