GGPeps — scoring against the rubric
Criterion-by-criterion scoring with the rubric anchors reproduced.
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.
§2Scoring against the rubric
The rubric is published in full so that a reader can check a judgement rather than take it. Each criterion is scored on an anchored zero-to-five scale, and the anchors are reproduced below alongside the score awarded, with the point on the scale the Institute judged this supplier to occupy.
§2.1Certificate-of-analysis completeness (25 % weight)
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, with the point awarded to GGPeps marked.
| 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 | Awarded |
| 4 | All critical fields present; one or two recommended fields absent | — |
| 5 | Every critical and recommended field present with traceable batch linkage | — |
| Score awarded: 3 of 5, contributing 15.0 of a possible 25 points to the total. | ||
§2.2Independent third-party testing record (25 % weight)
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, with the point awarded to GGPeps marked.
| 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 | Awarded |
| 5 | Systematic per-batch reporting across the catalogue with verifiable laboratory attribution | — |
| Score awarded: 4 of 5, contributing 20.0 of a possible 25 points to the total. | ||
§2.3Identity confirmation practice (15 % weight)
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, with the point awarded to GGPeps marked.
| 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 | Awarded |
| 4 | High-resolution mass spectrometry with deconvoluted average mass | — |
| 5 | Orthogonal identity with sequence confirmation for compounds where the sequence is contested | — |
| Score awarded: 3 of 5, contributing 9.0 of a possible 15 points to the total. | ||
§2.4Documentation transparency and consistency (15 % weight)
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, with the point awarded to GGPeps marked.
| 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 | Awarded |
| 4 | Consistent documentation with limitations acknowledged | — |
| 5 | Consistent documentation, limitations disclosed, and corrections issued when identified | — |
| Score awarded: 3 of 5, contributing 9.0 of a possible 15 points to the total. | ||
§2.5Storage, packaging and cold-chain evidence (10 % weight)
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, with the point awarded to GGPeps marked.
| Point | Anchor | |
|---|---|---|
| 0 | No information | — |
| 1 | Generic statements only | — |
| 2 | Storage conditions stated; shipment uncontrolled | — |
| 3 | Cold-chain used for sensitive lines | Awarded |
| 4 | Cold-chain documented with excursion handling | — |
| 5 | Documented conditions with compound-specific handling including light protection | — |
| Score awarded: 3 of 5, contributing 6.0 of a possible 10 points to the total. | ||
§2.6Responsiveness to documented enquiry (10 % weight)
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, with the point awarded to GGPeps marked.
| 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 | Awarded |
| 4 | Substantive response within 14 days with documents supplied | — |
| 5 | Substantive response within 7 days with documents and method details supplied | — |
| Score awarded: 3 of 5, contributing 6.0 of a possible 10 points to the total. | ||
§2.7Total
Table 8. Weighted total for GGPeps.
| Criterion | Weight, % | Score, 0–5 | Points |
|---|---|---|---|
| Certificate-of-analysis completeness | 25 | 3 | 15.0 |
| Independent third-party testing record | 25 | 4 | 20.0 |
| Identity confirmation practice | 15 | 3 | 9.0 |
| Documentation transparency and consistency | 15 | 3 | 9.0 |
| Storage, packaging and cold-chain evidence | 10 | 3 | 6.0 |
| Responsiveness to documented enquiry | 10 | 3 | 6.0 |
| Total 65.0 of 100 — C — partially conformant. The Institute reports the total to one decimal place and records that this overstates the precision of six anchored five-point judgements. | |||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.