| Food Safety Management | A documented food-safety management system covering hazards, preventive controls, sanitation, traceability, and corrective actions. | Hazard analysis completed; critical control points or preventive controls defined; deviations investigated and closed. | Food-safety plan, hazard-analysis records, sanitation logs, internal-audit reports, and corrective-action records. | HACCP principles; ISO 22000:2018 where certified. | China and export markets; certification is generally voluntary unless specifically required by a customer or authority. |
| Good Manufacturing Practice | Controlled facilities, hygienic personnel practices, validated cleaning, equipment maintenance, and documented production procedures. | Environmental hygiene, line clearance, batch records, equipment calibration, and controlled processing conditions. | Site procedures, training records, cleaning verification, calibration certificates, and batch-manufacturing records. | Applicable Chinese food-production requirements; destination-market GMP requirements where relevant. | All markets; exact requirements depend on product category and destination. |
| Quality Management System | Defined responsibilities for document control, supplier approval, nonconforming products, complaints, recalls, and continual improvement. | Controlled specifications; change-control approval; complaint trends reviewed; corrective and preventive actions tracked. | Quality manual, standard operating procedures, change-control forms, complaint logs, and CAPA reports. | ISO 9001:2015 where certified. | Applicable to both domestic and export supply chains; certification does not replace legal compliance. |
| Raw-Material Qualification | Ingredients approved against identity, purity, safety, origin, storage, and supplier-performance requirements. | Supplier risk classification; incoming identity testing; contaminant and adulteration screening based on risk. | Approved-supplier list, specifications, certificates of analysis, sampling records, and quarantine/release records. | Applicable food-safety standards and destination-market ingredient rules. | All markets; ingredient legality must be assessed separately for each destination. |
| Identity and Potency Testing | Finished products tested against approved specifications for declared active ingredients and critical quality attributes. | Assay results within specification; validated or verified analytical methods; representative sampling plan. | Finished-product certificate of analysis, laboratory worksheets, method references, and retained samples. | Applicable national food standards and recognized analytical methods. | All markets; claim substantiation and testing expectations vary by jurisdiction. |
| Microbiological Control | Controls for microbial contamination in raw materials, production areas, water, packaging, and finished products. | Testing against applicable limits for total microbial counts, pathogens, yeast, and mold where required. | Microbiology reports, environmental-monitoring records, water-testing results, and sanitation verification. | Applicable Chinese food-safety standards and destination-market microbiological criteria. | All markets; limits depend on product form and legal classification. |
| Contaminant and Adulterant Testing | Risk-based testing for heavy metals, pesticides, mycotoxins, residual solvents, undeclared pharmaceuticals, and other relevant contaminants. | Analytes selected according to ingredient origin, product type, known risks, and destination-market requirements. | Third-party laboratory reports, risk assessments, supplier declarations, and investigation records. | Applicable limits under Chinese food-safety standards and destination-market legislation. | All markets; testing frequency should be risk-based rather than assumed to be identical for every product. |
| Process Validation and Uniformity | Critical processes such as blending, filling, tableting, encapsulation, drying, and heat treatment are defined and controlled. | Blend uniformity, fill-weight variation, tablet weight, moisture, disintegration, or other product-specific attributes monitored. | Validation protocols, process qualification reports, in-process test records, and trend analyses. | Applicable GMP and food-production requirements for the product category. | All markets; exact tests depend on dosage form and formulation. |
| Packaging and Label Control | Packaging materials must be suitable for food contact and protect the product throughout its stated shelf life. | Artwork approval; label reconciliation; seal integrity; lot number, expiry date, storage conditions, and net-content checks. | Packaging specifications, artwork approvals, line-clearance records, packaging inspection reports, and reconciliation records. | China: GB 7718, GB 28050, and applicable product-specific standards. | China and export markets; labeling must be reviewed separately for each country or region. |
| Shelf-Life and Stability | Shelf life established using product-specific stability data under defined storage conditions. | Active-ingredient retention, moisture, appearance, microbial quality, packaging integrity, and other critical attributes monitored over time. | Stability protocol, time-point results, storage-condition records, and expiry-date justification. | Applicable food-safety and product-quality requirements in the target market. | All markets; accelerated studies may support development but should not automatically replace real-time data. |
| Traceability and Recall Readiness | Each batch traceable from incoming materials through production, packaging, release, distribution, and customer records. | Mock recall completed within a defined response time; reconciliation of quantities manufactured, released, held, and distributed. | Batch genealogy, distribution records, recall procedure, mock-recall report, and retention-sample log. | Food-safety management and applicable food-recall requirements. | All markets. |
| China Regulatory Classification | Product classification established before formulation, claims, packaging, and production planning. | Formula, permitted ingredients, dosage, claims, registration or filing pathway, and labeling aligned with the classification. | Regulatory assessment, formula review, filing or registration documentation where applicable, and approved label materials. | China Food Safety Law; applicable health-food registration or filing rules; GB 16740 where applicable. | Products placed on the Chinese market. |
| United States Export Readiness | Manufacturing and records support the requirements applicable to dietary supplements marketed in the United States. | Specifications, master manufacturing records, batch records, quality-control review, complaint handling, and release procedures maintained. | Applicable facility and product records, finished-product specifications, certificates of analysis, and recall documentation. | U.S. FDA 21 CFR Part 111; applicable provisions of the Federal Food, Drug, and Cosmetic Act. | United States; importer and product-specific obligations must also be assessed. |
| European Union Export Readiness | Formula, ingredients, claims, labeling, and food-safety controls reviewed against the requirements of the intended EU member state and product category. | Ingredient status, maximum levels where applicable, claim substantiation, allergen control, and traceability verified. | Ingredient compliance review, technical documentation, label assessment, and traceability records. | Directive 2002/46/EC and applicable EU food-information, health-claims, novel-food, and food-safety legislation. | European Union; national implementation and member-state requirements may differ. |
| Audit and Supplier Transparency | Manufacturers provide controlled access to relevant quality documentation and support customer, certification, or regulatory audits. | Audit findings categorized by risk; corrective actions assigned, documented, and verified for effectiveness. | Audit reports, certifications with scope and validity, corrective-action responses, and document-request records. | Customer quality agreements; applicable certification-scheme rules; national regulatory requirements. | All markets. |