Quality
An independently audited manufacturing standard
Our manufacturing standard is not a claim we make about ourselves, it is a certification an independent body audits and anyone can verify.
Most suppliers will tell you they follow good manufacturing practice. Far fewer submit that practice to an independent auditor and publish the result on a register you can check without asking them. Hengrui manufactures to NSF/ANSI 455-2, the GMP standard written specifically for dietary supplements, supported by HACCP food-safety systems and a facility governed to a pharmaceutical GMP cleanroom standard. This page explains what that means for the teams who have to qualify us.
NSF/ANSI 455-2: GMP for Dietary Supplements
NSF/ANSI 455-2 is a recognised Good Manufacturing Practice standard written specifically for dietary-supplement manufacturing, and it incorporates the US FDA’s 21 CFR Part 111 requirements. Certification is granted only after NSF, an independent third party, audits the facility against the standard, and it is maintained through recurring audits rather than issued once and left alone. For a buyer, that turns “we follow GMP” into an externally examined fact.
Written for dietary supplements, not adapted from a general food standard
Incorporates the US FDA’s 21 CFR Part 111 requirements
Granted and renewed on the basis of independent third-party audits
Listed on NSF’s public certification database
Certification you can verify without asking us
Our certification is listed on NSF’s public database, so your quality team can confirm it directly at source rather than relying on a PDF we email across. That matters during supplier evaluation, because a certificate sent by a supplier can be out of date or altered, while a live public register cannot. It gives procurement a concrete, independent trust point from the first day of the relationship.
What “audited” and “verifiable” actually mean
There is a real difference between a supplier that declares it is compliant, one that has been certified by an accredited third party, and one whose certification you can verify on a public register. The first asks for your trust, the last removes the need for it. For a quality team, a verifiable certification shortens supplier onboarding, strengthens the supplier-qualification file and reduces how much has to be taken on faith before the first order ships.
Self-declared: the supplier states it complies, and you take that on trust
Certified: an accredited third party audits compliance and issues the mark
Verifiable: that mark is listed on a public register you can check at any time
Certified under NSF’s China GMP program
We are also certified under NSF’s China GMP program, which applies NSF’s auditing discipline to manufacturing in China. For a European buyer sourcing from a Chinese manufacturer, it means the same independent body stands behind the site’s good-manufacturing-practice status, assessed against a defined standard rather than assumed. It is a second, China-specific layer of the same third-party assurance.
HACCP food-safety systems underneath
Beneath the GMP certification sits a HACCP system, the internationally used preventive method that identifies food-safety hazards and controls them at the critical points in production where they can be managed. Rather than catching problems by inspecting finished goods, HACCP is designed to stop them arising in the process in the first place. It is the food-safety foundation the certifications build on.
A facility governed to a pharmaceutical GMP cleanroom standard
A standard is only as good as the plant that runs it. Our facility is built and operated to a pharmaceutical GMP cleanroom standard, with controlled production environments, intelligent automated lines and an in-house testing centre. That is the physical discipline, controlled air and controlled process documented at every step, that makes consistent, certifiable output possible batch after batch.
Taken together, an audited dietary-supplement GMP standard, a public register you can check, HACCP underneath and a pharmaceutical-grade facility give your quality and procurement teams something to qualify against evidence, not adjectives.
Verifiable quality, not adjectives
Our approach
Identity checks, in-process controls, finished-product testing and full traceability, built into every batch.
Certifications
Each certification the facility holds, explained by what it covers and why a buyer should care.
Documentation
The batch and product records your quality, regulatory and customs teams file, and how each supports compliance.