Compliance defines what we manufacture, where we ship, and which markets we enter. Every WhiteningBright product passes the production-system and product-level controls required by its destination market. This page documents the certifications, audit cadence, and quality processes that underpin every shipment.
Production system certifications
The plant operates under four parallel quality management systems, each covering a distinct product line. Certificates of compliance are available on request and re-issued at every audit cycle.
| Certification | Scope | Issuing body |
|---|---|---|
| ISO 13485 | Medical-device QMS - whitening accelerator lights, applicator devices, syringe systems | T?V S?D |
| ISO 22716 | Cosmetic GMP - gels, pastes, powders, mouthwashes | SGS |
| BSCI | Business Social Compliance Initiative - labor practices and workplace conditions | amfori |
| SEDEX SMETA 4-Pillar | Ethical sourcing audit - labor, health & safety, environment, business ethics | SGS |
Product-level compliance by market
Beyond plant-level QMS, each product carries the registrations and notifications required by the markets it is sold in. Documentation is shipped with every export.
| Market | Required clearance | Coverage |
|---|---|---|
| United States | FDA establishment registration; MoCRA cosmetic facility listing | All cosmetic SKUs; device SKUs as applicable |
| European Union | CPNP cosmetic notification; CE marking for accelerator devices | All SKUs intended for EU sale |
| United Kingdom | SCPN (post-Brexit cosmetic notification); UKCA marking | All SKUs intended for UK sale |
| Australia | NICNAS / AICIS registration | All cosmetic SKUs |
| GCC region | SFDA registration; Halal certification on request | SKUs intended for Saudi Arabia, UAE |
Quality assurance process
Each production lot moves through the following control points before release.
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Incoming material verification
Active concentration assay, microbiological screening, packaging dimension check. Non-conforming materials are quarantined and returned to supplier.
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In-process control
pH, viscosity, fill weight measured at defined intervals across the production run. Out-of-spec batches trigger immediate line stop and investigation.
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Pre-shipment inspection
100% visual inspection plus AQL 2.5 statistical sampling for packaging integrity, labeling accuracy, and lot traceability codes.
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Documentation package
Each shipment includes Certificate of Analysis, MSDS, ingredient declaration, and origin documents formatted to the destination market's requirements.
Stability and shelf-life testing
Stability studies run for 12 months at 25 ?C / 60% RH (ICH long-term conditions) plus accelerated testing at 40 ?C / 75% RH. Findings inform expiry dating and storage instructions on every label. Custom market conditions (tropical, high-altitude) can be added on request.
Quality issue resolution
In the event of a customer-reported quality issue, our quality team responds within one business day with: (a) an initial root-cause hypothesis based on the affected lot record, (b) requested return samples for laboratory analysis, and (c) a corrective action plan within five business days. Compensation, replacement, or rework terms are defined in the supply agreement.
Request manufacturing information
Specifications, pricing, lead times — typical response within one business day.