| Formula and Ingredient Quality |
| Formula Transparency | Complete INCI list, ingredient function, concentration range, CAS number where applicable, and country-specific restrictions. | Formula specification, current INCI declaration, raw-material technical data sheets, allergen statement, and change-control procedure. | No undisclosed active, preservative, fragrance, colorant, or prostaglandin-analogue ingredient. Any formula change requires written approval and updated documentation. | 12% | High |
| Eye-Area Suitability | Suitability for application near the lash line, including irritation, sensitization, and accidental eye-contact risk. | Safety assessment, ophthalmologist or ocular-tolerance data where available, irritation and sensitization test reports, usage instructions, and contraindications. | Evidence must support the intended eye-area use. Avoid unsupported “ophthalmologist-tested” or “hypoallergenic” claims. Claims must match the tested product and dosage. | 12% | High |
| Active Ingredient Control | Identity, assay, purity, residual solvents, impurities, and batch-to-batch consistency of key actives. | Certificate of analysis, validated or qualified analytical method, reference standard information, supplier qualification records, and finished-product assay data. | Every commercial batch has defined specifications and passes identity, assay, impurity, and microbiological requirements before release. | 10% | High |
| Preservation System | Preservative selection, preservative concentration, water activity or equivalent risk assessment, and antimicrobial performance. | Preservative efficacy test protocol and report, commonly based on ISO 11930 or an appropriately justified equivalent method. | A water-based serum should pass a scientifically justified preservative efficacy test in the final commercial packaging, not only in a laboratory sample. | 10% | High |
| Microbiological Quality | Total aerobic microbial count and absence of specified objectionable microorganisms. | Finished-batch microbiological test report, sampling plan, laboratory accreditation or qualification evidence, and environmental-monitoring summary. | For products intended for the eye area, ISO 17516 commonly uses a total aerobic mesophilic microorganism limit of ≤10² CFU/g or mL, with specified pathogens absent; confirm the applicable market requirement. | 12% | High |
| Testing and Manufacturing Controls |
| Stability and Shelf Life | Physical, chemical, microbiological, and packaging stability throughout the proposed shelf life and after opening. | Real-time and accelerated stability protocol, time-point results, in-use or open-package data, storage conditions, and expiry or PAO justification. | No unacceptable change in appearance, odor, pH, viscosity, assay, impurities, microbial quality, package function, or applicator performance during the claimed period. | 10% | Medium |
| Packaging Compatibility | Compatibility between the serum, bottle, brush, wiper, closure, label, and secondary packaging. | Compatibility study, extractables or leachables risk assessment where relevant, transport simulation, leakage testing, and component specifications. | No leakage, swelling, cracking, discoloration, adsorption, clogging, applicator deterioration, or unacceptable chemical migration under normal and foreseeable conditions. | 8% | Medium |
| Cosmetic GMP | Manufacturing, hygiene, documentation, deviation, complaint, recall, and traceability controls. | Current ISO 22716 certificate or equivalent GMP audit report, batch records, sanitation procedures, training records, deviation and CAPA logs, and mock-recall results. | Manufacturing and quality systems should align with ISO 22716 principles, with traceability from raw-material lot to finished-product batch and distribution records. | 10% | High |
| Quality Laboratory Capability | Independence, competence, method suitability, sample retention, and result integrity. | Laboratory qualification records, ISO/IEC 17025 accreditation scope where available, method validation or verification, chromatograms, raw data, and chain-of-custody records. | Critical tests must be performed by a qualified laboratory using methods suitable for the specific serum matrix and reported with acceptance criteria and actual results. | 8% | Medium |
| Regulatory and Commercial Readiness |
| European Union Compliance | Responsible Person, Cosmetic Product Safety Report, Product Information File, CPNP notification, compliant labeling, and claims substantiation. | CPSR signed by a suitably qualified safety assessor, PIF index, CPNP confirmation, label artwork, ingredient compliance review, and claims dossier. | Before placing the product on the EU market, the responsible organization must complete the applicable requirements under Regulation (EC) No. 1223/2009, including safety assessment, PIF, responsible-person details, and CPNP notification. | 8% | High |
| United States Compliance | MoCRA facility registration, product listing, safety substantiation, adverse-event records, and serious adverse-event reporting. | Facility-registration details, product-listing record, safety substantiation file, complaint procedure, adverse-event log, and recall or corrective-action procedure. | For applicable products, align with the U.S. Modernization of Cosmetics Regulation Act requirements. Serious adverse events generally must be reported to FDA within 15 business days of receipt. | 8% | High |
| UK and Other-Market Readiness | Market-specific responsible person, product notification, safety file, language, labeling, and restricted-ingredient review. | Country-by-country regulatory matrix, notification records where required, translated labels, local contact details, and current restricted-substance screening. | Supplier must identify which party owns compliance in each target market and provide a documented gap analysis before production or export. | 5% | Medium |
| Claims and Marketing Support | Evidence for claims such as “helps lashes look longer,” “conditioning,” “strengthening,” or “reduces breakage.” | Consumer-use study, instrumental data, product-use protocol, statistical analysis, claim wording, and limitations of the evidence. | Use cosmetic appearance claims supported by product-specific evidence. Avoid drug-like growth, treatment, disease, or permanent-effect claims unless the product is legally authorized for that category. | 5% | High |
| Change Control and Supply Continuity | Control of raw-material, formula, process, site, packaging, and test-method changes. | Written change-control policy, notification lead time, approved-vendor list, dual-sourcing plan, minimum order quantity, lead time, and business-continuity plan. | No material change is implemented without documented risk assessment, regulatory review, stability impact assessment, and customer approval when required. | 5% | Medium |
| Final Supplier Score | Weighted evaluation using documented evidence rather than presentation quality or price alone. | Completed audit checklist, evidence register, corrective-action plan, sample approval record, and signed quality agreement. | Recommended decision rule: 85–100 = preferred; 70–84 = conditional approval with CAPA; below 70 = do not approve. Any critical safety or regulatory failure should override the numerical score. | 100% | Critical |
