| Supplier identity and traceability |
A legally registered manufacturing site with a unique lot or batch identification system. |
Business registration, manufacturing-site address, organizational chart, lot-coding procedure, and traceability records. |
Cross-check registration details, conduct a remote or on-site audit, and perform a one-step-forward/one-step-back traceability test. |
High: Undisclosed production site or incomplete batch records. |
| Good Manufacturing Practice (GMP) |
Manufacturing controls appropriate to the destination market, such as U.S. dietary supplement GMP under 21 CFR Part 111 or applicable food-supplement GMP requirements in the European Union. |
Current GMP certificate, audit report, corrective-action records, sanitation program, pest-control records, and equipment-maintenance logs. |
Confirm certificate scope and validity with the issuing body; review critical GMP procedures and recent deviations. |
High: Certificate does not cover the actual product or manufacturing location. |
| Ingredient identity and specification |
Every active ingredient has a defined identity, source, strength, purity range, and test method. |
Raw-material specifications, supplier qualification records, certificates of analysis, authentication method, and allergen status. |
Compare specification with the formula and independently test representative raw-material samples using an appropriately validated method. |
High: Generic descriptions such as “proprietary blend” without quantitative ingredient details. |
| Finished-product potency |
Measured nutrient and active-compound levels meet the approved product specification throughout shelf life, including justified overage limits where applicable. |
Finished-product certificate of analysis, validated assay method, stability protocol, and batch-release records. |
Use an independent laboratory for pre-shipment and periodic confirmation testing; compare results with the approved specification. |
Medium: Potency is reported without method, uncertainty, or sampling information. |
| Microbiological safety |
Results comply with the applicable product-category and destination-market limits for pathogens, indicator organisms, yeast, and mold. |
Microbiological certificate of analysis, sampling plan, laboratory accreditation, environmental-monitoring records, and water-quality records where relevant. |
Test risk-based lots using an ISO/IEC 17025-accredited laboratory and verify the analytical methods and detection limits. |
High: No pathogen testing for products containing dairy, plant proteins, botanicals, or moisture-sensitive ingredients. |
| Heavy metals and environmental contaminants |
Lead, cadmium, mercury, arsenic, and other relevant contaminants comply with the legal limits of the target market and the product-specific risk assessment. |
Elemental-analysis reports, risk assessment by ingredient origin, supplier controls, and documented sampling plan. |
Confirm whether arsenic is speciated when relevant; review ICP-MS or equivalent validated testing and compare with destination-market requirements. |
High: Testing covers only one metal or is based solely on a supplier declaration. |
| Mycotoxins, pesticides, and residual solvents |
Testing is based on botanical origin, extraction process, agricultural exposure, and the legal requirements of the destination market. |
Multi-residue pesticide report, mycotoxin report, residual-solvent report, cultivation or sourcing records, and process-flow diagram. |
Use risk-based sampling and confirm laboratory capability for the required analyte panel and reporting limits. |
High: Botanical ingredients are supplied without geographic or agricultural-source information. |
| Allergen and cross-contact control |
All intentionally added allergens and reasonably foreseeable cross-contact risks are identified, controlled, and correctly declared. |
Allergen matrix, cleaning-validation records, production-sequencing procedure, label review, and allergen test results where required. |
Compare formulation, facility materials, and label statements; verify cleaning controls and targeted testing. |
High: Shared equipment is used without documented validated cleaning controls. |
| Label and claims compliance |
Ingredient names, serving size, nutrition information, warnings, net quantity, lot code, expiry date, and claims comply with the destination-market rules. |
Final artwork, formula-to-label reconciliation, substantiation dossier, translation review, and regulatory assessment. |
Conduct a country-by-country label review before printing; verify that disease-treatment claims are not used where prohibited. |
High: Marketing language implies prevention, treatment, or cure of a disease without authorization. |
| Novel food and ingredient authorization |
Novel ingredients are authorized or otherwise legally permitted in each intended market before commercialization. |
Ingredient legal-status assessment, authorization reference where applicable, history-of-use evidence, and intended-use evaluation. |
Check official regulatory databases and obtain a written assessment from a qualified regulatory professional. |
High: The supplier cannot document the regulatory status of a new extract, microorganism, or isolated compound. |
| Stability and shelf life |
Shelf life is supported by real-time or scientifically justified accelerated stability data under defined storage conditions. |
Stability protocol, time-point results, packaging-compatibility data, storage requirements, and expiry-date justification. |
Review trends for potency, moisture, water activity, microbial quality, organoleptic properties, and package integrity. |
Medium: Shelf life is assigned solely from similar products or packaging claims. |
| Packaging and transport protection |
Packaging protects against moisture, oxygen, light, contamination, and physical damage according to product sensitivity. |
Packaging specification, food-contact compliance documentation, seal-integrity results, transport qualification, and temperature or humidity requirements. |
Review packaging material declarations and conduct shipment simulations or data-logger monitoring for sensitive products. |
Medium: Product is shipped without defined temperature, humidity, or handling controls. |
| Change control and deviation management |
Material, process, equipment, site, packaging, and formula changes require documented approval before implementation. |
Change-control procedure, deviation log, corrective and preventive action records, and customer-notification process. |
Review recent changes and verify that re-testing, label updates, and regulatory assessments were completed. |
High: Supplier can substitute ingredients or sites without prior written approval. |
| Independent laboratory capability |
Critical tests are performed by competent laboratories, preferably accredited to ISO/IEC 17025 for the relevant methods. |
Accreditation schedule, method validation or verification records, laboratory scope, sample chain of custody, and raw data availability. |
Confirm that the laboratory’s accreditation scope covers the specific analyte and method used. |
Medium: Certificates lack laboratory identification, method number, or test date. |
| Recall and complaint readiness |
A documented recall procedure supports rapid lot identification, customer notification, product withdrawal, and root-cause investigation. |
Recall plan, mock-recall results, complaint log, adverse-event procedure, emergency contacts, and product-liability insurance evidence. |
Review the latest mock-recall exercise and confirm response-time expectations in the supply agreement. |
High: No 24-hour escalation process for serious quality or safety incidents. |
| Import and market-entry documentation |
Commercial invoices, packing lists, certificates, product specifications, customs information, and destination-market registrations are complete and consistent. |
Export documents, certificate of origin where required, product dossier, importer details, customs classification, and regulatory filings. |
Reconcile documents before shipment and confirm responsibilities under the agreed Incoterms and quality agreement. |
Medium: Product name, formulation, quantity, or consignee details differ across documents. |
| Supplier approval decision |
Approve only when critical safety, legality, traceability, testing, and corrective-action requirements are closed and documented. |
Completed supplier questionnaire, audit report, risk rating, approved specification, quality agreement, and signed corrective-action plan. |
Use a risk-based scorecard with defined approval thresholds and periodic requalification. |
High: Commercial price or delivery performance is prioritized over unresolved safety or compliance findings. |