| Business and Production Authorization | Confirm that the actual production site holds the licenses and permits required for its product category and intended market. In China, requirements depend on whether a product is classified as ordinary food, health food, or another regulated category. | Current business and production-license details; product-category scope; verification through the relevant official authority where available. | A trading company’s credentials may not establish that the factory making the product is authorized to produce it. |
| Food Safety Management System | Assess documented controls for hazards, sanitation, supplier approval, traceability, corrective actions, and product release. HACCP-based systems and ISO 22000 certification can support evaluation but should not be treated as substitutes for applicable legal requirements. | Current certificates, certification scope and site details; audit summaries; hazard-control and corrective-action records. | A certificate is useful only when it covers the relevant site and manufacturing activities. |
| Vegetarian and Vegan Ingredient Control | Review all ingredients, processing aids, carriers, capsule materials, and flavor components. Check for animal-derived ingredients such as gelatin, shellac, dairy, or certain processing aids, as relevant to the product’s claim. | Full ingredient and processing-aid disclosures; supplier declarations; cross-contact controls; applicable third-party vegan certification records, if claimed. | “Vegetarian” and “vegan” claims have different meanings, and ingredient names alone may not reveal processing aids or cross-contact risks. |
| Raw-Material Qualification | Check supplier approval, identity testing, specifications, origin records, and risk-based screening for contamination or adulteration. | Raw-material specifications; supplier audit or qualification records; certificates of analysis; traceability documentation. | Ingredient quality and authenticity affect the safety, consistency, and stated composition of the finished product. |
| Finished-Product Testing | Confirm that testing is appropriate to the formulation and destination-market requirements. Depending on product risk, this may include identity, declared nutrient or active-content levels, microbiological quality, and contaminant testing. | Batch-specific certificates of analysis; test methods and acceptance limits; laboratory accreditation and scope where applicable; out-of-specification investigation records. | A generic or undated test report does not demonstrate that a specific production batch meets its specifications. |
| Product Classification and Claims | Determine the product’s regulatory classification in each destination market and review whether its ingredients, claims, and intended use are permitted. China’s registration or filing requirements for health foods are distinct from requirements for ordinary foods. | Classification rationale; applicable registration or filing records where required; approved or reviewed label and claim documentation. | Regulatory status is product- and market-specific; a factory’s general food credentials do not establish authorization for every supplement product. |
| Labeling and Packaging | Check ingredient and allergen declarations, serving information, net contents, lot identification, dates, storage instructions, and claims against the rules of the target market. Packaging should be suitable for the product and its storage conditions. | Approved artwork; label review checklist; packaging specifications; evidence supporting label statements. | Labeling rules vary by jurisdiction, and claims that are acceptable in one market may be restricted in another. |
| Traceability and Recall Readiness | Verify that raw materials and finished batches can be traced through production and distribution, with a documented process for investigating complaints and managing recalls. | Mock-recall results; lot-coding examples; complaint and recall procedures; records linking ingredients to finished batches. | Effective traceability helps identify affected products quickly if a safety or quality issue arises. |
| Quality Consistency and Change Control | Review batch-release criteria, production records, deviation handling, and controls over changes to ingredients, suppliers, processes, or packaging. | Product specifications; representative batch records; change-control procedure; stability or shelf-life data supporting the stated expiry period. | Unreviewed changes can affect product composition, label accuracy, quality, or regulatory status. |