Heightened assurance, by design.
PureOne™ is our heightened-assurance program — for when an application needs more than documentary confidence. You buy a defined level of assurance, not just a material.
Not every material carries the same risk.
In regulated pharma and biopharma supply chains, complexity and change-control expectations keep rising — yet not every material carries the same risk. Conventional distribution supplies materials as they are, under the manufacturer’s name, with variable documentation and no consistent qualification layer. When an application is critical, that is not enough.
PureOne makes the level of assurance explicit and selectable. Materials are supplied under the Axcura name with independent analytical qualification on top of vendor qualification — with change control and documented, traceable data — so you can match assurance to your risk profile and regulatory exposure.
Evidence, not just paperwork.
- Supplied under the Axcura name — Axcura stands behind the material, not just the paperwork that came with it.
- Analytical material qualification — Independent analytical testing on top of technical vendor qualification — evidence, not just documentation.
- Change control and notification — Defined change management so you are informed before anything that matters to your filing moves.
- Documented, traceable data — Results you can place directly into your own dossier, with full traceability back to source.
Scale the assurance to your risk.
Each category defines a material’s quality standard, grade and purity — and the depth of analytical qualification PureOne applies. Trusted Goods and PureOne share the same categories; PureOne adds independent analytical qualification, scaled to the category.
Elemental | Advanced | Platinum | |
|---|---|---|---|
| Quality Standard | ISO 9001 | ISO 9001 + GMP¹ | GMP¹ |
| Grade | Non-compendial | Compendial | Compendial |
| Add. Parameter | — | Standard | Low Bioburden / Low Endotoxin |
| Technical vendor qualification | ● | ● | ● |
| Independent analytical qualification | ● | ● | ● |
| Certificate of Analysis (CoA) | ● | ● | ● |
| Analytical method verified | — | ● | ● |
| Analytical method validated | — | — | ● |
| Change control & notification | — | ● | ● |
| Quality agreement on request | — | ● | ● |
¹ GMP: IPEC-PQG and/or EXCiPACT™, incorporating ICH Q7 elements.
Need analytically qualified material for a critical application?
Tell us the substance and the tier you're considering — we'll map the qualification path and come back within two working days.
Talk to Axcura