Built to pass
the audit.
Every batch we ship is governed by a documented quality system — GMP (PIC/S), ISO 22000, HACCP and JAKIM Halal in Malaysia, backed by an in-house QC lab, ICH-condition stability and full batch traceability. This is the page our auditors, QA reviewers and procurement partners read first.
Certifications
Certified, and documented.
Download the live certificates below. Malaysian operations carry the full set; the Guangzhou plant is certified to GMP and HACCP. We don't claim what we can't evidence — scope by site is set out underneath.
GMP · PIC/S
MalaysiaPharmaceutical-grade Good Manufacturing Practice across production, hygiene and documentation.
BSI
Download PDFHACCP — MS 1480:2019
MalaysiaHazard analysis and critical control points to the Malaysian food-safety standard.
BSI
Download PDFISO 22000
MalaysiaFood Safety Management System — the standard we hold (not ISO 9001).
Certification body
Download PDFJAKIM Halal
MalaysiaHalal certification for ingredients, process and facility, issued by JAKIM.
JAKIM
Download PDFKKM MeSTI
MalaysiaMakanan Selamat Tanggungjawab Industri food-safety scheme.
Ministry of Health Malaysia
Download PDFLesen Pengilangan PBT
MalaysiaLocal-authority manufacturing licence for the Balakong plant.
PBT / local authority
Available on requestFigures and items shown in italics are awaiting source documents — send them and they go live.
Certification scope
What's certified, where.
- ✓ GMP · PIC/S
- ✓ ISO 22000 (food safety)
- ✓ JAKIM Halal
- ✓ HACCP — MS 1480:2019
- ✓ KKM MeSTI
- ✓ Lesen Pengilangan PBT
- ✓ GMP
- ✓ HACCP
ISO 22000 and Halal are not currently claimed for the Guangzhou plant. China certification scope is GMP and HACCP.
In-house QC laboratory
Tested before it ships.
Identity, potency, purity and microbial safety verified in-house. No batch is released on a supplier certificate alone.
HPLC
Assay & potency of actives.
Microbiology
TPC, yeast & mould, and pathogen screening.
Heavy metals
Elemental contaminant screening by ICP / AAS.
Moisture & physical
Karl Fischer / LOD, plus disintegration and hardness on solid dose.
Raw-material ID
Every incoming lot verified against specification before release to production.
Finished-product release
Certificate of Analysis issued per batch — nothing ships on a supplier COA alone.
QA release
Every batch, fully documented.
From incoming raw material to QA sign-off, each stage is recorded against the batch record — so any unit traces end to end.
Incoming materials
Every raw and packaging lot quarantined and QC-tested on receipt.
Dispensing
Verified weigh-off under laminar airflow, independently double-checked.
In-process checks
Critical parameters checked at each stage against the batch record.
Finished-product testing
Assay, microbial and physical testing before release.
QA release
Independent QA sign-off against specification — not production.
Records & retains
Retained samples archived; full batch genealogy on file.
Stability
Shelf-life, substantiated.
ICH-condition stability testing supports every shelf-life claim — real-time and accelerated, under Malaysia's Zone IVb climate.
Accelerated
Long-term · Zone IVb
Climate zone
Protocol basis
Traceability
From raw lot to finished batch.
Forward and backward traceability. Any finished unit traces to its raw-material lots, equipment, operators and QC results — and back. Mock-recall capability maintained.
Batch genealogy
Lot-level links from material to finished unit.
Recall readiness
Targeted lot recall and periodic mock-recall drills.
Document control
Versioned SOPs, specs and master batch records.
Change & deviation
Controlled change, deviation and CAPA workflow.
Facility & environment
Controlled where it counts.
Cleanroom classification
Classified, controlled production zones.
HVAC & filtration
Temperature, humidity and pressure control with HEPA filtration.
Purified water
Validated RO water system.
Gowning & hygiene
Personnel gowning, hand hygiene and entry controls.
Segregated flow
Separated material, personnel and waste flows to prevent cross-contamination.
Pest & sanitation
Documented pest-control and sanitation program.
Audit-ready
Come and inspect.
We host customer and third-party audits and answer supplier questionnaires as standard. Batch records, validation protocols, SOPs, specifications and COAs are available for review under NDA.
Partner with our production.
For manufacturers, distributors and brand owners who need GMP- and ISO 22000-grade production at scale.