Weitai’s Quality Infrastructure

• ISO 22716:2007: International Cosmetics GMP
• US GMPC: FDA MoCRA-compliant (2024+)
• ISO 13485: Medical device quality management
• 80,000m²: GMP-standard ISO Class 100,000 cleanrooms
• 99% imported: Raw materials from verified global suppliers

Raw Material Testing

• Identity verification (IR spectroscopy, HPLC)
• Purity and potency testing per specification
• Microbiological: total plate count, E. coli, S. aureus, P. aeruginosa
• Heavy metals: lead, mercury, arsenic, cadmium
• COA verification against purchase specifications

In-Process Quality Control

• pH monitoring at emulsification stages
• Viscosity measurement for consistency
• Particle size analysis for emulsions
• Weight verification and visual inspection

Finished Product Testing

• Microbiology: total plate count, pathogens, yeast/mold
• Challenge testing: preservative efficacy per USP/EP
• Stability: accelerated (40C/75% RH) + real-time
• Package compatibility and COA per batch

Batch Traceability

Every production batch generates complete documentation: batch production records, QC test results, Certificate of Analysis, deviation reports, and full material traceability linking finished products to raw material lot numbers.