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Supplement Quality Assurance | OEM/ODM Factory
As a Shenzhen-based health supplement manufacturer, we built our QA system around one promise: every batch tells the same story in data. From supplier qualification and pharmacopeial raw-material ID tests to in-process controls under 21 CFR Part 111 (Dietary Supplement cGMP), ISO22000/FSSC22000 food safety systems, and HACCP risk mapping, your product is safeguarded through measurable checkpoints. We release only with signed COAs, retain samples for 36 months, and maintain full traceability from lot to label—so your brand can scale confidently across Amazon, Shopify, pharmacies, and retail.
Certifications & Regulatory Framework
We align to the frameworks your channel requires: Dietary Supplement cGMP (21 CFR 111) for U.S.; EU 852/2004 + EFSA claim discipline; China GB standards & Blue-Hat pathways guidance; GCC/Middle East Halal and Arabic labeling; optional Kosher and Organic ingredient sourcing. Our facility quality manual includes document control, training matrices, sanitation master schedules, pest control, allergen programs, and vendor-approval SOPs. Each certificate and SOP is available during virtual or on-site audits.
- FDA & GMP certified production
- Halal, Organic, and Kosher options available
- COA, MSDS, and third-party testing for every batch
- Compliant with Amazon, Shopify, and global e-commerce standards
Supplier Qualification & Raw-Material Integrity
Trust Begins Before Your Ingredients Arrive
We operate an Approved Supplier List (ASL) with risk scoring (origin, prior OOS, biological/chemical risk). Onboarding includes GMP questionnaires, third-party audits, and trial lots. Every inbound raw material undergoes:
- Identity testing (e.g., FTIR/HPTLC for botanicals; ICP-OES/ICP-MS for minerals)
- Assay/potency versus monographs (USP/EP/ChP where applicable)
- Contaminants: heavy metals (Pb/Cd/Hg/As), pesticide screens, PAHs, residual solvents
- Microbiology: TAMC, TYMC, pathogens (Salmonella, E. coli, Staph aureus) Only materials that pass QC release move to production; non-conformances trigger CAPA and supplier re-qualification.
In-Process Controls (IPCs) & Line Clearance
Before each batch we perform line clearance (no cross-mixing), verify scale calibration, and review Master Manufacturing Record (MMR). During blending, encapsulation, tableting, and filling we record:
- Blend uniformity (RSD targets)
- Capsule/tablet physicals: weight, thickness, hardness, friability, disintegration
- Fill weights & torque checks for bottles/sachets
- Metal detection & sieve integrity
- Environmental monitoring (airborne particulates, settle plates in high-risk zones) Real-time IPCs reduce rework and stabilize yields, protecting potency and label claims.
Finished Product Testing & COA Release
We issue lot-specific Certificates of Analysis that cover: identity, assay/potency, microbiology, heavy metals, organoleptics, water activity, and physical checks. Assays reference USP/EP/AOAC or validated in-house methods. Results are linked to retain samples and digital LIMS records. Optional third-party verification (USP/NSF-style) and Informed-Sport screening for sports SKUs are available.
Example COA Panel (Typical):
| Test Category | Method/Ref | Spec Example | Result Example |
|---|---|---|---|
| Identity (Botanical) | HPTLC (USP) | Match to reference | Pass |
| Potency (Vitamin D3) | HPLC/UV | 100% ±10% label claim | 102% |
| Heavy Metals | ICP-MS | Pb <0.5 ppm; Cd <0.3 ppm | Pass |
| Microbiology | USP <61>/<62> | Salmonella/E. coli absent | Absent |
| Disintegration | USP <2040> | ≤30 minutes | 12 min |
Stability Program & Shelf-Life Justification
We run accelerated (e.g., 40°C/75%RH) and real-time stability for each dosage form—capsules, tablets, powders, liquids, and gummies. Protocols include assay degradation curves, micro growth checks, water activity, organoleptics, and packaging interaction (sorption, migration). Stability data informs expiry dating, “Best Before”, and overage strategy to ensure label claims through end-of-life—especially critical for probiotics, enzymes, and liposomal liquids.
Packaging & Label Quality Control
We validate packaging for barrier, compatibility, and child resistance: HDPE/PET bottles, foil sachets, paper cans, droppers, and spouted pouches. QC includes torque, seal integrity, leak tests, UV ink adhesion, migration, and desiccant sizing based on water-activity targets. Labels pass regulatory pre-checks: Supplement Facts/Nutrition Facts formatting, allergen and warning statements, country-of-sale claims (U.S. structure/function disclaimer; EFSA-permitted wording for EU), Halal/Kosher/Organic marks, lot/expiry and scannable barcodes/QR.
Third-Party Testing & Client Audit Portal
Beyond our in-house lab, we can route split samples to accredited third parties for impartial verification (potency, micro, heavy metals, contaminants, banned-substance screens). Clients receive portal access to SOPs, training logs, cleaning records, IPC sheets, and COAs per SKU, with NDA protection. Schedule remote video walk-throughs or on-site audits—our QA desk supports your retail and regulatory submissions.
Get Proof of Quality—Before You Place an Order
Ready to turn specs into sell-through? Request a batch-specific sample COA, our QA Audit Pack (SOP list, testing matrix, stability outline), and a 15-minute QA consult with our Shenzhen team. We’ll walk you through GMP controls, dosage-form testing plans (capsules, powders, liquids, gummies), market-specific labeling checks (U.S./EU/GCC), and realistic lead times (pilot to scale). NDA welcome. No fluff—just data you can show buyers and regulators.
Contact our OEM Advisor today and get a quote within 24 hours.
