Quality Certifications & Standards | Novoremedy

Quality Certifications & Standards

Pharmaceutical-grade quality systems ensuring every product meets the highest standards

“Quality isn’t just about passing tests—it’s about building it into every step from concept through delivery to customer.”

Our Quality Philosophy: Quality by Design

1. DESIGNED IN, NOT TESTED IN

We design quality into products from the beginning using Quality by Design (QbD) principles—not just test at the end and hope.

2. PHARMACEUTICAL STANDARDS

We hold ourselves to pharmaceutical industry standards (ICH guidelines, FDA regulations) even though supplements have lower requirements.

3. COMPREHENSIVE TESTING

We test beyond minimum requirements: stability, bioavailability, contamination, consistency.

4. CONTINUOUS IMPROVEMENT

Quality systems evolve. We regularly review and improve processes, incorporate new technologies, and learn from every batch.

5. TRANSPARENCY

Complete documentation, traceability, and availability of Certificates of Analysis. Nothing hidden.

Our Certifications

Industry-leading certifications validating our commitment to quality

GMP CERTIFICATION

Good Manufacturing Practices

GMP ensures products are consistently produced and controlled according to quality standards.

Our Status:
  • All manufacturing partners are cGMP certified
  • FDA-registered facilities (USA)
  • 21 CFR Part 111 compliance (dietary supplements)
  • 21 CFR Part 210 & 211 awareness (pharmaceutical standards)
  • Cosmetic GMP compliance (Vietnam facility)
What This Means: Validated processes, trained personnel, clean facilities, equipment calibration, documentation and traceability, regular audits.
🏆

ISO 22000 CERTIFICATION

Food Safety Management

Our herbal extract partners (Nanovex, Vietplantex) are ISO 22000 certified.

What It Ensures:
  • Food safety throughout supply chain
  • Hazard analysis and control
  • Prerequisite programs
  • Management system requirements
  • Continuous improvement processes
🕌

HALAL & KOSHER

Religious Dietary Requirements

Certain herbal extracts carry Halal and Kosher certifications for religious dietary requirements.

Available For:
  • Hesperidin
  • Coffee Oil
  • Black Pepper Extract
  • Gac Oil
  • Other select ingredients
🇻🇳

VIETNAM MOH REGISTRATION

Official Government Approval

Official government approval after comprehensive review and testing.

Our Achievement:
  • 9 products successfully registered
  • 100% approval rate (no rejections)
  • Comprehensive dossier review
  • Testing at certified Vietnamese labs
  • Ongoing compliance requirements
What This Validates: Product safety, quality standards, label accuracy, manufacturing standards, regulatory compliance.
🇺🇸

FDA COMPLIANCE (USA)

Federal Regulatory Standards

All USA operations comply with FDA regulations for dietary supplements and cosmetics.

For Dietary Supplements:
  • 21 CFR Part 111 (cGMP)
  • DSHEA compliance
  • GRAS ingredients
  • Proper labeling (21 CFR 101)
  • Adverse event reporting system
For Cosmetics:
  • 21 CFR Parts 700-740
  • Ingredient safety (no prohibited substances)
  • Labeling requirements
  • Good manufacturing practices

Our Multi-Stage Quality Control Testing

Comprehensive testing at every step ensures consistent pharmaceutical-grade quality

1
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RAW MATERIAL TESTING

Before any ingredient enters production:

Supplier Qualification Approved vendor list only
COA Review Every incoming lot verified
Identity Testing HPLC, TLC, FTIR confirmation
Potency Verification Confirm active content
Microbial Testing Bacteria, yeast, mold limits
Heavy Metals Below safe limits
Quality Gate: If any material fails testing, it’s rejected or quarantined pending investigation. Never used in production.
2
⚙️

IN-PROCESS TESTING

During manufacturing:

Weight Checks Correct ingredient amounts
Blend Uniformity Homogeneous mixing
Environmental Monitoring Clean room conditions
Equipment Verification Proper operation and cleanliness
Process Parameters Temperature, time, pressure
3
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FINISHED PRODUCT TESTING

Before release to market:

Appearance Visual inspection
Identity Confirms correct product
Potency/Assay Active ingredients at label claim (±5-10%)
Dissolution Release rate within specs
Uniformity Content consistent unit-to-unit
Microbial Testing Total count, pathogens absent
Heavy Metals Below CA Prop 65 limits
Moisture Within acceptable range
Certificate of Analysis (COA): Every batch receives COA documenting all test results. Available upon request with batch number.
4
📊

STABILITY TESTING

Ongoing quality monitoring:

Accelerated Stability 40°C/75%RH, 3-6 months
Long-Term Stability 25°C/60%RH, 12-24+ months
Real-Time Monitoring Samples tested at intervals
Photostability Light-sensitive products

Purpose: Establish expiration dating, confirm shelf life, detect degradation, support label claims throughout product life.

5
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RETENTION SAMPLES

For every batch:

  • Retain samples for duration of shelf life + 1 year
  • Available for future testing if needed
  • Investigation capability if customer issue arises
  • Complete traceability maintained

Comprehensive Quality Management Systems

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Standard Operating Procedures (SOPs)

Written procedures for every process—from ingredient receipt to finished product release.

📝

Batch Records

Complete documentation for every batch produced with full traceability from raw material supplier through to customer.

🔍

Traceability

Complete forward and backward traceability. If problem identified, can trace affected batches immediately.

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Continuous Improvement

Quarterly quality reviews, trend analysis, CAPA (Corrective and Preventive Actions), ongoing training.