| Supplier Legal Identity | Confirm the supplier's legal entity, manufacturing address, authorized contact, and scope of operations. | Current business registration details, official facility address, quality contact, and documented supply-chain ownership. | Information is consistent across contracts, quality documents, invoices, audit records, and shipping documents. | Required |
| Quality Management System | Assess whether documented procedures control deviations, change control, complaints, corrective actions, training, and record retention. | Quality manual, standard operating procedure index, deviation and CAPA procedures, training records, and change-control process. | Quality responsibilities are independent from commercial sales activities and records are attributable, legible, contemporaneous, original, and accurate. | Required |
| GMP Status | Determine whether the material is manufactured under an applicable current good manufacturing practice framework. | Current GMP certificate or inspection documentation issued by a recognized regulatory authority or qualified certification body, where applicable. | Certificate scope covers the relevant site, dosage form or active ingredient activity, and product category. Certification is independently verified. | Required |
| Regulatory Registration | Check whether the manufacturing site and product activity require registration or listing in the intended market. | Verifiable regulatory registration or listing details, where legally applicable, plus the registration scope and current status. | Registration is current and relevant to the actual manufacturing site. Registration alone is not treated as proof of product approval. | Required |
| Facility and Utilities | Review facility zoning, environmental controls, water systems, compressed gases, HVAC, cleaning, and maintenance controls. | Facility overview, room classification information where applicable, preventive-maintenance records, environmental-monitoring summaries, and utility qualification records. | Controls are appropriate for the peptide's manufacturing stage and contamination, cross-contamination, and mix-up risks. | Required |
| Process Validation | Evaluate control of synthesis, purification, isolation, drying, filling, packaging, and critical process parameters. | Process-flow diagram, critical-process-parameter summary, validation or verification report, in-process controls, and deviation history. | Critical steps have scientifically justified limits and documented evidence demonstrating consistent process performance. | Required |
| Identity and Purity | Confirm that the supplied peptide is the stated sequence and that purity is measured using validated or qualified analytical methods. | Batch-specific certificate of analysis, chromatograms, mass-spectrometry or equivalent identity data, assay result, and impurity profile. | Methods are suitable for the molecule and results meet the agreed specification. Acceptance limits are defined before purchase. | Required |
| Analytical Method Controls | Assess whether methods used for identity, purity, assay, residual solvents, water content, and related substances are controlled. | Method references, validation or verification summaries, system-suitability criteria, reference-standard information, and instrument records. | Methods demonstrate appropriate specificity, accuracy, precision, linearity, range, and robustness for their intended use, when applicable. | Required |
| Impurities and Residuals | Review control of deletion sequences, oxidized or deamidated variants, aggregation, residual solvents, reagents, catalysts, and process-related impurities. | Impurity specification, analytical profile, residual-solvent results, risk assessment, and documented toxicological or process justification where needed. | Limits are scientifically justified and aligned with the intended use, route of administration, and applicable regulatory expectations. | Required |
| Microbiological Quality | Determine whether bioburden, microbial limits, bacterial endotoxins, sterility, and container-closure controls are relevant to the product. | Batch-specific microbiological results, endotoxin report, sterility test where applicable, sampling plan, and validated test-method information. | Requirements match the material's intended use. Sterility claims are not accepted without appropriate aseptic or sterilization controls and supporting data. | Required |
| Laboratory Independence | Verify who performed testing and whether the laboratory is competent and appropriately controlled. | Laboratory accreditation or qualification records, analyst training, equipment calibration, method records, and chain-of-custody documentation. | Critical release testing is performed by a qualified laboratory using calibrated equipment and controlled records. Independent confirmation is recommended for high-risk materials. | Recommended |
| Batch Traceability | Ensure each container can be linked to raw materials, processing records, test results, packaging, release, and shipment. | Unique batch number, manufacturing date, retest or expiry date, lot genealogy, packaging record, release authorization, and distribution records. | Traceability is complete from incoming materials through final delivery, with no unexplained gaps or relabeling. | Required |
| Raw-Material Qualification | Review the qualification and control of amino acids, coupling reagents, solvents, resins, catalysts, water, and other critical inputs. | Approved-vendor list, incoming-test requirements, supplier audits, material specifications, certificates, and traceability records. | Critical raw materials are sourced from approved vendors and are tested or otherwise qualified before use. | Required |
| Storage and Transport | Confirm protection from temperature, moisture, light, oxygen, contamination, and unauthorized access during storage and shipment. | Labeling requirements, temperature or humidity limits, packaging qualification, shipping-condition records, and excursion-management procedure. | Transport conditions are defined, monitored where necessary, and supported by stability or handling data. | Required |
| Stability and Retest Period | Assess whether the assigned retest or expiry period is supported by stability data for the actual formulation and container. | Real-time and accelerated stability summaries, storage conditions, test intervals, degradation profile, and container-closure information. | Retest or expiry dating is supported by data from representative batches and includes relevant chemical and microbiological attributes. | Required |
| Data Integrity | Check whether electronic and paper records are protected against alteration, deletion, backdating, or unauthorized access. | Audit-trail controls, access management, backup procedures, electronic-record policies, original data, and documented review procedures. | Records comply with applicable data-integrity principles and can be reconstructed throughout the product lifecycle. | Required |
| Supplier Auditability | Establish the buyer's right to conduct a qualification audit or receive an independent audit report. | Quality agreement, audit plan, recent audit report, response to observations, and corrective-action completion evidence. | Critical observations have documented root-cause analysis, corrective actions, effectiveness checks, and agreed completion dates. | Recommended |
| Quality Agreement | Define responsibilities for specifications, testing, release, deviations, complaints, recalls, changes, subcontracting, and regulatory communication. | Signed quality agreement with clear notification timelines and approval requirements for critical changes. | No critical quality or regulatory responsibility is left undefined between the purchaser and supplier. | Required |
| Clinical or Human-Use Claims | Separate research-use materials, pharmaceutical APIs, compounded preparations, and approved finished medicinal products. | Product classification, intended-use statement, applicable authorization, labeling, and regulatory documentation for the target jurisdiction. | No supplier may imply that a research-grade peptide is approved, sterile, safe for human use, or clinically effective without appropriate authorization and evidence. | Required |
| Final Qualification Decision | Use a documented, risk-based decision process before onboarding or placing an order. | Completed supplier questionnaire, risk assessment, audit outcome, document-review checklist, approval record, and periodic requalification schedule. | Supplier is approved only after critical gaps are closed or formally accepted by qualified quality and regulatory personnel. | Required |
