| 1. Product Definition | Material identity | Define the product as Urolithin A bulk powder and specify whether the material is intended for food, dietary supplement, research, or other regulated use. | The intended use, jurisdiction, dosage form, and applicable regulatory requirements are documented before quotation. | Product specification, intended-use statement, regulatory checklist | Before supplier screening |
| 2. Supplier Screening | Quality-system capability | Request manufacturing-site details, quality certifications, audit history, batch-traceability procedures, change-control policy, and complaint-handling process. | Supplier can provide controlled specifications, batch records, certificates of analysis, and documented deviation and CAPA procedures. | Supplier questionnaire, quality agreement draft, certification copies | 3–10 business days |
| 3. Sample Request | Representative sampling | Request a sample identified by batch or lot number, together with the matching certificate of analysis and storage instructions. | Sample documentation is traceable to the physical sample and includes manufacturing date, retest or expiry date, and storage conditions. | Sample request form, sample label, matching certificate of analysis | 5–15 business days |
| 4. Sample Testing | Identity and assay | Verify identity using a suitable chromatographic or spectroscopic method and test assay using a validated or qualified HPLC method appropriate for the matrix. | Identity conforms to the approved reference standard; assay meets the buyer-approved specification, commonly defined as not less than 98.0% for high-purity bulk material. | Independent laboratory report, chromatograms, reference-standard details | 5–15 business days |
| 5. Contaminant Control | Safety and purity testing | Assess residual solvents, elemental impurities, pesticides where relevant, microbial quality, and other contaminants required by the intended market. | Results comply with the approved specification and applicable limits, such as ICH Q3C for residual solvents and ICH Q3D principles for elemental impurities where applicable. | Contaminant test report, method references, laboratory accreditation details | 7–20 business days |
| 6. Physical Properties | Appearance and handling | Define color, odor, powder flow, particle-size distribution, moisture or loss on drying, bulk density, and packaging requirements according to the finished-product process. | Material matches the approved visual standard and remains suitable for blending, encapsulation, or other planned processing. | Physical-property specification, inspection record, particle-size report | During sample approval |
| 7. Sample Finalization | Approval status | Compare the supplier sample with the approved specification and document any conditional approval, deviations, or required corrective actions. | Written approval is issued only after identity, assay, safety, physical properties, packaging, and documentation are accepted. | Signed sample-approval form, deviation log, final specification | 1–5 business days after test completion |
| 8. Contract and Quality Agreement | Commercial and quality terms | Specify approved material, minimum order quantity, price basis, Incoterms, payment terms, delivery schedule, shelf life, batch documentation, audit rights, change notification, and nonconformance handling. | No substitution, process change, site change, or specification change is permitted without documented review and prior written approval. | Supply contract, quality agreement, approved specification, change-control clause | 5–15 business days |
| 9. Pre-Shipment Control | Batch release package | Require the final certificate of analysis, batch or lot number, manufacturing date, retest or expiry date, quantity, packaging record, and transport conditions before shipment. | Documents are reviewed and approved before dispatch; shipping labels and product documentation match the purchase order. | Pre-shipment checklist, final certificate of analysis, packing list, shipping records | 2–5 business days before shipment |
| 10. Incoming Quality Control | Receipt and verification | Quarantine the shipment, inspect container integrity, verify quantity and labels, review documents, and test identity before release to production or inventory. | All containers are intact and traceable; identity passes; any additional testing meets the approved incoming-material plan. | Goods-receipt record, sampling plan, inspection report, release or rejection decision | 1–5 business days after receipt |
| 11. Storage and Stability | Inventory protection | Store in the supplier-defined conditions, normally in a tightly closed, light-protected container in a cool, dry area, unless the approved specification states otherwise. | Temperature, humidity, stock rotation, and container-opening records are maintained; material is used within the stated shelf-life or retest period. | Storage log, environmental monitoring record, inventory status report | Continuous monitoring |
| 12. Reordering Procedure | Reorder point and continuity | Set the reorder point using average monthly consumption, supplier lead time, minimum order quantity, safety stock, and demand variability. Reconfirm the current specification before each order. | A purchase order is released when available stock reaches the approved reorder point; the supplier confirms the same specification and provides updated batch documentation. | Inventory forecast, reorder calculation, purchase order, supplier confirmation | Review weekly or monthly |
| 13. Periodic Requalification | Ongoing supplier performance | Review on-time delivery, batch acceptance, deviations, complaints, test trends, changes, audit findings, and certificate-of-analysis consistency. | Supplier remains qualified only when performance is acceptable and no unresolved critical quality issue is present. | Supplier scorecard, annual review, trend report, audit or requalification record | At least annually or risk-based |