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Quality Policy

Not Just a Standard.
A Non-Negotiable
Commitment.

Quality at NuCoreBio is not a department or a checkbox — it is the foundational principle that every formula, every batch, and every shipment is built on. We apply pharmaceutical-grade analytical methods to nutritional science because your customers’ trust depends on it.

100%
Batch Testing Rate
4×
QC Checkpoints Per Production Run
3rd
Party Independent Lab Sign-Off
Our Quality Standard
Pharmaceutical-Grade Precision on Every Production Run
What “pharmaceutical-grade” means in practice — not in marketing language.
HPLC POTENCY VERIFICATIONEvery active ingredient confirmed at stated specification before capsule fill
ICP-MS HEAVY METALS PANELLead, Cadmium, Arsenic, Mercury — every batch, USP & EU limits
FULL MICROBIAL SCREENTotal plate count, Yeast/Mold, Coliforms, E.coli, Salmonella — per batch
PESTICIDE MULTI-RESIDUE SCREENGC-MS / LC-MS — all botanical raw materials
INDEPENDENT 3RD-PARTY SIGN-OFFAccredited lab confirms before any batch ships

COA, MSDS, TDS, and 3rd-party reports issued pre-shipment on every production run — standard, not on request.

🏆GMP Certified Network
📋ISO 9001:2015
🥗FSSC 22000
🔬HPLC + ICP-MS Every Batch
3rd-Party Lab Verified
🌙Halal Certified Lines
98% Icariin Purity Standard
Our Quality Statement

What We Commit to on Every Order

NuCoreBio is committed to delivering bioactive formulas and ingredients that meet or exceed the specifications agreed with every client — without exception, without shortcuts, and without compromise based on cost or volume. Every batch produced through our manufacturing partner network must pass full internal QC and independent third-party laboratory verification before it is authorized for shipment. If it doesn’t pass, it doesn’t ship.
🔬
NuCoreBio Quality Management
Effective 2024 · Reviewed Annually · Binding on All Production Partners
Quality Pillars

Four Principles That Define Our Standards

These are not aspirations. They are operational commitments embedded into every stage of our production and supply chain.

01 / 04
🧬
Ingredient Purity at Molecular Level
Quality begins before formulation. Every raw material lot undergoes HPLC marker verification, ICP-MS heavy metals testing, and pesticide residue screening before it enters our production network. Sub-specification lots are rejected — not discounted.
02 / 04
⚙️
Pharmaceutical-Grade Manufacturing Conditions
All formulas are produced in D-Grade cleanroom environments meeting pharmaceutical manufacturing standards. Contamination controls, air handling, and environmental monitoring run continuously throughout every production run.
03 / 04
📊
Independent Third-Party Verification
We do not self-certify quality. Every commercial batch receives independent verification from an accredited third-party laboratory — potency, heavy metals, microbial safety, and pesticide screen. The COA reflects actual test results, not internal targets.
04 / 04
🔄
Continuous Improvement & Traceability
Full lot-level traceability from raw material sourcing through final batch release. Deviation reports, CAPA processes, and annual quality management reviews ensure our standards continuously improve — not just maintain.
Testing Protocol

What We Test, How We Test, Why It Matters

A transparent breakdown of every testing stage — from raw material receipt through final batch release.

Four-Stage Quality Control Protocol

Most supplement manufacturers test once at end of production. NuCoreBio’s network runs QC at four distinct stages — problems caught early, not after 50,000 capsules are filled.

📥
Stage 1
Incoming Raw Material QC
Every Lot

Before any raw material enters production, it must pass our incoming QC protocol. Every lot is independently verified — no material accepted on supplier COA alone.

HPLC Identity & Potency
ICP-MS Heavy Metals
TLC / UV-Vis Confirmation
Moisture / LOD
Particle Analysis
Organoleptic Check
⚗️
Stage 2
In-Process Quality Checks
During Production

QC checkpoints at blending, encapsulation, and packaging. Fill weight consistency verified at ±2% tolerance. Environmental monitoring running throughout.

Fill Weight ±2% tolerance
Capsule Integrity
Blend Homogeneity
Environmental Monitoring
Label / Lot Code Verification
🏁
Stage 3
Finished Product QC (Internal)
Every Batch

Full finished product QC internally before 3rd-party lab. Active potency confirmed. Complete microbial panel. Heavy metals repeated on finished product. Any deviation triggers investigation.

HPLC Finished Potency
Total Plate Count
Yeast & Mold
Coliform / E.coli
Salmonella
Heavy Metals
Pesticide Screen
🏛️
Stage 4
Independent 3rd-Party Lab Sign-Off
Pre-Shipment · Every Batch

No batch ships without independent laboratory verification from an ISO 17025-accredited facility. 3rd-party COA issued directly to client. Both internal and external COAs accompany every shipment.

ISO 17025 Accredited Lab
HPLC Potency Confirmation
ICP-MS: Pb, Cd, As, Hg
Full Microbial Panel
COA Issued to Client
Pesticide GC-MS/LC-MS
98%
Icariin purity standard — HPLC verified on every production run
This level of precision isn’t standard in the supplement industry. It’s pharmaceutical-grade quality applied to nutritional science.
97%
Berberine standardization — pharmaceutical-grade extraction protocol
Our berberine meets the same purity standards applied to pharmaceutical raw materials, not just supplement-grade benchmarks.
🧪
ICP-MS Heavy Metals — USP & EU Limits
Lead (Pb), Cadmium (Cd), Arsenic (As), Mercury (Hg) — tested on every incoming raw material AND finished product. Results must comply with the stricter of USP 232 and EU Commission Regulation 2023/915 limits.
🦠
Full Microbial Panel — USP & EU Pharmacopoeia
Total Aerobic Count, Yeast & Mold, Coliforms, E.coli, Salmonella, S. aureus — tested against USP <2021> and Ph.Eur. 5.1.4 acceptance criteria for dietary supplements.
Quality Certifications

Third-Party Verified Quality Standards

Certifications are the independent confirmation that our quality commitments are real — not self-declared.

🏆
GMP / cGMP
Current Good Manufacturing Practice
Full compliance with 21 CFR Part 111 cGMP standards. Production partners are GMP-certified and subject to regular third-party audits — the baseline quality standard for dietary supplement manufacturing worldwide.
Applicable Markets
FDA USGlobalAll Markets
📋
ISO 9001:2015
Quality Management System
International quality management certification covering design, production, documentation, and continuous improvement. Demonstrates systematic quality control and process-based management at every operational stage.
Recognized by
EUAustralia TGAHealth Canada
🥗
FSSC 22000
Food Safety System Certification
GFSI-recognized food safety management system based on ISO 22000 and HACCP principles. Comprehensive hazard analysis, critical control points management, and systematic food safety risk control throughout production.
Recognized by
EU EFSAUK FSASoutheast Asia
🌙
Halal
Halal Certified Production
Dedicated Halal-certified production lines. Full Halal documentation per batch — ingredient-level status verified, segregated production, independent Halal audit annually. Opens access to 1.8 billion Muslim consumers globally.
Compatible With
JAKIM MalaysiaMUI IndonesiaSFDA Saudi
✡️
Kosher
Kosher Certified
Kosher-certified production capabilities. OU (Orthodox Union) compatible documentation. Dedicated Kosher production runs with full segregation from non-Kosher materials for US, EU, and Israeli markets.
Markets
USAIsraelEurope
🔬
3rd-Party Verified
ISO 17025 Laboratory Accreditation
All final batch verification by ISO 17025-accredited independent labs. Accreditation means methods, instruments, and personnel are independently verified — your COA reflects true results, not optimistic in-house reporting.
Accreditation
ISO 17025Every BatchPre-Shipment
SOPs & Traceability

Full Traceability From Source to Shipment

Every ingredient lot, production batch, and test result is documentable — from the field where a botanical was grown to the capsule in your client’s hand.

Documented at Every Stage

Our traceability system allows us to identify the exact raw material lot in any finished product batch, trace it to the supplier, and provide the full testing history at every stage. In the event of a regulatory inquiry, we can respond immediately.

01
Supplier Qualification & Approved Vendor List
All raw material suppliers qualified against a documented AVL. New suppliers pass a qualification audit before acceptance. Re-qualification conducted annually or upon any change in supplier manufacturing site.
02
Lot-Level Raw Material Traceability
Every incoming raw material lot receives a unique internal lot number linked to supplier COA, our independent QC results, and every production batch where the material was used — permanently queryable.
03
Batch Records & Production Documentation
Complete batch records maintained for every production run: raw material lots used, equipment IDs, operator logs, in-process results, environmental monitoring, and final QC sign-off. Retained 3 years minimum.
04
Deviation & CAPA Management
Any deviation from established SOPs triggers a formal deviation report. A CAPA (Corrective and Preventive Action) plan is implemented and effectiveness verified before the next production run.
📁
3yr
Minimum batch record retention per GMP. Available for audit on request.
🔗
100%
Lot-level traceability from raw material origin to finished product — every lot queryable.
🔄
12mo
Maximum supplier re-qualification cycle. All approved vendors audited annually.
What Traceability Means for You
Respond immediately to any regulatory inquiry with full documentation
Rapid root-cause analysis if any quality concern is raised
Targeted recall capability — batch-specific, not market-wide
Proof of compliance for distributor and retailer audits
Full supply chain transparency for premium brand positioning
Client Commitments

What You Can Hold Us Accountable To

These are not policies we describe — they are operational commitments with direct consequences if not met.

📊
Specification Compliance Guarantee
Every batch meets the agreed specification or we remake it at no charge. No negotiation, no exceptions. If it fails to meet spec, we do not ship it and we do not charge for it.
Potency within ±5% of label claim
All contaminants below regulatory limits
Non-compliant batches quarantined — not shipped at discount
📋
Documentation Transparency
All test results — internal and third-party — are provided as issued, without editing or selective reporting. If a result shows a deviation, you see it. That is the basis of a trusted manufacturing relationship.
Internal COA alongside 3rd-party COA
All test results as issued — unedited
Deviations reported proactively, not concealed
🔄
Batch-to-Batch Consistency
Reorders of the same formula are tested against original batch specifications. Potency and purity must match within agreed tolerance. We maintain locked formulas with controlled raw material lots.
Locked formula specifications per client
Batch-to-batch potency comparison on reorders
Change notification required before any formula adjustment
🌍
Market-Specific Compliance
For clients in regulated markets (US, EU, AU, CA), quality documentation is formatted to meet each market’s specific requirements — not a generic one-size-fits-all package.
US: USP method compliance, Supplement Facts ready
EU: Ph.Eur. methods, EU contaminant limits
Halal / Kosher certification as applicable
Proactive Issue Communication
If a quality concern arises — from a supplier change, a test deviation, or a regulatory change — we contact you before your next production order, not after 50,000 capsules are filled.
Supplier quality changes notified immediately
Test deviations communicated before production proceeds
Proposed solutions provided with every issue notification
🛡️
Client Audit Rights
Active clients may request access to batch records, QC documentation, and production facility audit reports for their specific products. We do not hide behind confidentiality agreements on quality evidence.
Batch records available on request (active clients)
Production partner audit reports shareable under NDA
Annual quality review available for key accounts

The NuCoreBio Quality Guarantee

We are confident enough in our quality systems to back every order with a clear, unambiguous guarantee. This is not small print. This is how we do business.

Specification Match Guarantee
Every batch meets the agreed specification or we remake it at no charge. No negotiation, no exceptions.
Documentation Complete Guarantee
COA, MSDS, TDS, 3rd-party test report, and all applicable certificates ship with every order. Missing document = 24-hour delivery or credit.
Regulatory Compliance Guarantee
Formulas for a specific market are confirmed compliant before production starts. We do not produce non-compliant product and then charge for reformulation.
Batch Consistency Guarantee
Reorders tested against original batch specifications. Your product is the same product, every time.
100%
of commercial batches independently verified by accredited 3rd-party laboratory before shipment authorization
0×
Batches shipped with known specification failures in our production history

“Quality is not what you measure at the end of production. It is what you build into every decision from raw material sourcing through final dispatch. At NuCoreBio, quality is the product. Everything else — formula design, manufacturing, logistics — serves that commitment.”

See It for Yourself
Request a Sample COA &
Evaluate Our Quality Firsthand
Words are easy. Request a free sample of any formula — evaluate the product and documentation yourself. That is the fastest way to understand what pharmaceutical-grade quality actually looks like in a supplement.
Full COA included with every sample
3rd-party test report on request
No commitment required
Sample shipped within 14 days
📋 Contact Us