Quality control asks whether a material conforms, but in practice the question is conforms by which method, measured when. A material that conformed on receipt can fall outside specification through storage or processing.
1. Verified by lot
Quality is confirmed per lot, and COAs are issued per lot. On continuing supply we check whether the difference from the previous lot is acceptable. Natural materials move by lot, so knowing the observed distribution — not only the specified minimum — is what gives a design its safety margin.
2. When the figure is guaranteed
Whether a specified value is measured at manufacture or guaranteed at end of shelf life changes its meaning. For these groups the difference decides whether a design holds.
| Material group | Sensitive to | What we confirm |
|---|---|---|
| Lactic acid bacteria, bifidobacteria | Temperature, humidity | When the count is guaranteed; storage range; handling after opening |
| Anthocyanin extracts | Heat, light, pH | Light-barrier packaging, temperature, shelf life |
| Carotenoids | Light, oxygen | Packaging, handling after opening |
| Hygroscopic powders | Humidity | Handling after opening, sub-division size |
Cell counts illustrate it. Materials are specified as “N cells per gram” while notifications are written “N cells per daily intake reference”. The inclusion rate sits between them, and whether the figure is guaranteed at end of shelf life decides how much margin you need.
3. GMP-compliant manufacturing
Our affiliated health-food OEM/ODM business (TENMARU SEIYAKU Co., Ltd.) operates GMP-compliant facilities. That lets us assess materials from the side that receives them and turns them into product — a material can conform to specification and still be wrong for the dosage form, and that judgement can be made at the selection stage.
4. Weighing control
We take in the Ministry of Health’s published import violation records (1,682 cases) and track the pattern relevant to the items we handle. What the record shows is that most violations concern control, not the quality of the material.
For high-intensity sweeteners, exceedances of the use standard have been published with “inadequate weighing control” as the cause. Where a material is dosed at grams per kilogram, a premix reduces weighing error by an order of magnitude — solved by the choice of material rather than by care on the line.
Documents we provide
- Specification — per item
- COA — per lot
- Storage conditions and shelf life
- Dosage-form fit — particle size, solubility, hygroscopicity, heat resistance
- Samples — small quantities for trial
Related: Specification & Analysis / Quality Assurance (service) / Contact