| 1 |
Regulatory Classification |
Confirm whether the product is regulated as a food supplement, functional food, or another category in the target market. |
Check permitted ingredients, maximum nutrient levels, claims rules, notification requirements, and import conditions before production. |
Regulatory assessment, ingredient compliance statement, product specification, and market-specific label review. |
Critical |
| 2 |
Manufacturing Controls |
Evaluate the facility’s food safety and quality systems, including hygiene, allergen control, sanitation, and process validation. |
Prefer documented preventive controls or HACCP-based procedures, batch records, deviation handling, and internal audit processes. |
Current certification where applicable, audit summary, manufacturing flow chart, and quality manual contents. |
Critical |
| 3 |
Ingredient Identity and Potency |
Verify the exact form, source, concentration, standardization, and active amount of every functional ingredient. |
Define an acceptance range for active content and identify whether the declared amount is measured before or after processing. |
Ingredient specifications, identity test results, assay method, certificate of analysis, and allergen declaration. |
Critical |
| 4 |
Contaminant and Microbiological Testing |
Assess risks from pathogens, yeast and mold, heavy metals, pesticides, solvents, mycotoxins, and undeclared substances. |
Testing frequency and limits should be risk-based and aligned with the destination market’s applicable requirements. |
Recent batch-specific laboratory reports, sampling plan, method references, and laboratory accreditation details. |
Critical |
| 5 |
Packaging and Label Information |
Check the ingredient list, serving size, net quantity, allergen statement, nutrition information, warnings, storage conditions, and contact details. |
Labels should include lot identification, best-before or expiry information, and claims that are substantiated and permitted in the target market. |
Approved artwork, packaging specification, label compliance checklist, and packaging component declarations. |
Critical |
| 6 |
Shelf Life and Stability |
Determine whether potency, appearance, taste, moisture, and microbiological quality remain within specification throughout shelf life. |
Request real-time stability data where available; accelerated studies can support development but may not replace market-specific requirements. |
Stability protocol, time-point results, proposed shelf life, storage conditions, and packaging compatibility data. |
High |
| 7 |
Packaging Integrity and Logistics |
Review protection from moisture, oxygen, light, tampering, breakage, and temperature exposure during transport and storage. |
Define container-closure requirements, pallet configuration, transport conditions, and acceptable temperature or humidity excursions. |
Packaging drawings, seal or closure test results, transport simulation data, carton specifications, and storage instructions. |
High |
| 8 |
Minimum Order Quantity and Lead Time |
Compare minimum order quantities, production capacity, raw-material availability, and standard replenishment timelines. |
Document sample, pilot, and commercial quantities separately; obtain confirmed lead times for both initial and repeat orders. |
Commercial quotation, capacity statement, production schedule, raw-material sourcing plan, and order cut-off calendar. |
Medium |
| 9 |
Long-Term Supply Terms |
Clarify pricing, forecast commitments, payment terms, allocation during shortages, service levels, and remedies for delayed delivery. |
Use written terms covering forecast changes, minimum annual volume, safety stock, notice periods, and delivery performance expectations. |
Supply agreement, service-level schedule, price-adjustment formula, business continuity plan, and escalation procedure. |
High |
| 10 |
Traceability and Change Control |
Ensure every finished batch can be traced to raw materials, packaging components, production records, testing, and distribution. |
Require advance written notice and approval for changes to ingredients, suppliers, process parameters, specifications, packaging, or production sites. |
Traceability procedure, mock recall results, change-control form, deviation records, complaint procedure, and retention policy. |
Critical |