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BIOSPHERE-AI

Quality & compliance

Required documentation differs by destination market. We prepare each item against your destination checklist so shipments do not stall at the border.

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Required documentation differs by destination market. We prepare each item against your destination checklist so shipments do not stall at the border.

Certificate numbers and validity can be verified against scanned copies upon inquiry.

2

DEKRA certificates: GMPC · ISO 22716

4

Test dimensions: experience · efficacy · stability · compatibility

10

Safety gates before release

Class 100kGMP

Cleanroom standard

QC

QC flow: six independent checkpoints (overview)

Incoming, in-process and finished goods each keep their own record. This page is about certifications and the documents an export shipment needs; the 36 individual control points — method, acceptance basis, sampling and record — live on the Quality Control page.

  1. Incoming Inspection

    Supplier COA review + retained samples for self-inspection

  2. In-Process Patrol Inspection

    Key parameters recorded every 30 minutes

  3. Semi-Finished Product Release

    Appearance / pH / viscosity / centrifugation

  4. Microbiological Testing

    Total plate count and pathogens; non-conforming product is not filled

  5. Finished Product Release

    Full test report + retained samples stored

  6. Retained Sample Traceability

    Samples kept for the full shelf life and available for re-testing at any time

Four-property testing

"It was tested" is not an answer — four dimensions, each with defined test content and batch-linked reports.

  • Experience

    Sensory, skin-feel and scent evaluation — run at the sample stage, not after mass production.

  • Efficacy

    Active verification and clinical efficacy testing — claims without evidence never reach the label.

  • Stability

    Heat, cold and centrifuge testing across the shelf life — no separation, discolouration or loss of potency.

  • Compatibility

    Packaging compatibility and preservative challenge testing — formula-and-bottle chemistry settled before shipping.

Ten safety gates: six key checkpoints

Ten gates in total — microbiology, heavy metals, packaging, stability and more — traceable at source, controlled in process, risk flagged early. The six checkpoints buyers ask about most:

  1. 01

    Incoming inspection

    Every raw-material batch tested on arrival; failures never enter storage.

  2. 02

    Formula review

    Efficacy, compliance and cost reviewed together before production release.

  3. 03

    Pilot scale-up

    Process validation between sample and mass production — batch consistency is locked here.

  4. 04

    In-line patrol

    Real-time quality monitoring with automatic deviation alerts.

  5. 05

    Finished-goods testing

    Full inspection before release, with four-property reports filed per batch.

  6. 06

    Release sign-off

    Quality lead signs off; batch records and retained samples stay auditable.

Required documents depend on where the goods are shipped

Export documentation

Required documents depend on where the goods are shipped

The EU requires CPNP registration and a Product Information File. Many Southeast Asian countries require product notification. The Middle East requires SFDA or SASO. We prepare the document set based on the destination, not after a shipment is held at customs.

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EXPORT CREDENTIALS

Export Certifications & Originals

Wherever your goods ship, the matching registration is here. Two HALAL certificates (international Halal + U.S. AHF) cover the Middle East and Southeast Asia. CPNP and FDA registrations cover the EU and the U.S. respectively. MSDS and COA are issued with each batch.

  • HALAL Certification
    HALAL CertificationMiddle East / Indonesia market
  • AHF HALAL (American Halal Foundation)
    AHF HALAL (American Halal Foundation)North American halal market
  • EU CPNP Registration
    EU CPNP RegistrationEU territory
  • U.S. FDA Registration
    U.S. FDA RegistrationCosmetic facility registration

How do you ensure batch 2 matches batch 1? Can issues be traced?

Three things: trial production runs on the same line as the bulk order (no factory switch), independent records at three checkpoints (incoming materials, in-process, finished goods), and retention samples for every batch. The process covers a four-attribute test (user experience, efficacy, stability, compatibility) plus ten safety gates, from incoming material inspection to finished product release. Each finished unit is tied to a unique traceability code; batch information is searchable. Every efficacy claim is backed by a third-party report — if supporting evidence cannot be produced for a direction, we say directly that we cannot do it.

What certifications do you hold? Can they be verified?
GMPC, ISO 22716:2007 (both DEKRA certified), HALAL, FDA facility registration, EU CPNP, SGS, CE. Certificate numbers and validity periods can be verified against the scanned copies.
Can you provide reports for efficacy claims?
Stability, compatibility, microbial, and preservative challenge tests are completed in our in-house laboratory. Human efficacy and safety testing is outsourced to qualified third-party organizations — the value of such reports lies precisely in the fact that they are not issued by us.

Send us the destination list, and we handle the documentation.

Tell us which market the goods are going to, and we will reply with a list of documents required and an estimated timeline.

Start Inquiryhuanggw20@gmail.com