Quality Assurance
At Earay Bio-Tech, quality is not just a standard; it is our fundamental commitment to every client. Each step of our quality control process ensures every batch of botanical extract meets the highest standards of purity, potency, and safety.
Our Certifications
- GMP Certified – Pharmaceutical-grade production standards
- ISO 9001:2015 – Quality Management System
- ISO 22000:2018 – Food Safety Management
- HACCP Certified – Food safety hazard control
- KOSHER Certified – Dietary compliance
- HALAL Certified – Islamic dietary compliance
- USDA Organic – Organic certification
- NON-GMO Verified
Quality Control Process
1. Raw Material Inspection
All incoming raw materials undergo identity testing (HPLC/TLC), heavy metal screening (ICP-MS), pesticide residue analysis, and microbial testing.
2. In-Process Control
During extraction, critical parameters including temperature, pressure, solvent ratios, and processing time are continuously monitored.
3. Finished Product Testing
- Active Compound Content: HPLC or UV spectrophotometry
- Heavy Metals: Lead, Arsenic, Cadmium, Mercury (ICP-MS)
- Microbiology: TPC, Yeast & Mold, E. coli, Salmonella
- Residual Solvents: GC-MS per ICH Q3C
- Pesticide Residues: Multi-residue screening per EU/US
4. Documentation & Traceability
Every product ships with a Certificate of Analysis (COA). Complete batch records maintained for 3+ years.
Our Laboratory
Equipped with Agilent 1260 HPLC, Agilent 7890B GC-MS, PerkinElmer NexION ICP-MS, Shimadzu UV-2600, and Sartorius microbiology workstation.