Integrated Quality Control System & Critical Control Points

Certified Manufacturing & Compliance Foundation

Our operations are built on globally recognized quality and food safety systems:
cGMP · HACCP · ISO 9001 · ISO 22000 · FSSC 22000 · KOSHER · HALAL · FDA Registration · SC License (China Food Production License)

We align our products with international regulatory frameworks to support global market access.

1. Supplier Qualification & Raw Material Integrity

Strict supplier approval
Only audited and compliant suppliers are accepted into our system.

Batch-by-batch release control
Every raw material and excipient is tested before use.
Materials that fail internal standards are rejected.

Comprehensive testing scope
Includes active content, contaminants, heavy metals, microbiology, and physicochemical parameters.

2. In-Process Quality Control

Full-cycle monitoring
Quality checkpoints are implemented across the entire production process.

Standardized manufacturing execution
Operations strictly follow cGMP and FSSC 22000 requirements.

Regulatory alignment
Dedicated teams track global regulatory updates to ensure continuous compliance.

3. Analytical Testing & Laboratory Assurance

Dual-layer testing system
Routine testing is conducted in-house.
Independent verification is performed by accredited third-party laboratories.

Pharmacopoeia-based stability studies
Stability testing follows Chinese, USP, and European Pharmacopoeia standards.
Ensures consistent product quality throughout shelf life.

4. Specialized Risk Control Systems

Allergen management
Strict segregation and validated cleaning procedures minimize cross-contamination risk.

Multi-attribute compliance capability
Products can be controlled and documented as:
Non-GMO · Vegan · Gluten-Free · Halal · Kosher

5. Audit System & Continuous Improvement

Frequent external audits
Regular audits by certification bodies and global partners, including unannounced inspections.

Closed-loop quality improvement
Internal audit systems combined with root cause analysis (RCA).
Corrective actions are implemented to continuously enhance performance.

Dosage Form–Specific Quality Control Systems

Softgel Capsules

Oxidation-sensitive system control
Softgels often contain oils (Omega-3, botanical lipids).
We apply controlled encapsulation, low-oxygen processing, and antioxidant systems.

Shell integrity & sealing validation
Strict control of gelatin/glycerin ratios ensures capsule elasticity and stability.
Leakage and deformation risks are minimized.

Content uniformity
Advanced filling systems ensure precise dosage consistency in every capsule.

Hard Capsules

Powder flowability control
Granulation and particle size optimization improve filling accuracy.

Fill weight precision
Automated encapsulation systems ensure tight weight variation limits.

Capsule compatibility
Supports gelatin and HPMC capsules, including vegan formulations.

Tablets

Compression force optimization
Balanced hardness and disintegration performance through controlled tableting parameters.

Disintegration & dissolution compliance
Tested according to pharmacopeia standards to ensure bioavailability.

Coating stability
Film coating systems improve moisture resistance and product stability.

Powders & Granules

Particle size control (Mesh customization)
Supports 8–350 mesh depending on application requirements.

Bulk density consistency
Ensures uniform filling performance and packaging efficiency.

Moisture & caking control
Anti-caking systems and controlled drying processes maintain flowability.

Gummies

Active ingredient stability
Low-temperature processing protects heat-sensitive actives (e.g., vitamins).

Sugar system & texture control
Optimized pectin/gelatin systems ensure consistent texture and shelf stability.

Microbiological control
Strict hygiene and water activity control reduce contamination risk.

Liquid Formulations

Solubility & dispersion systems
Advanced emulsification and homogenization technologies ensure uniformity.

Preservation system validation
Microbial stability ensured through validated preservative systems.

Packaging compatibility
Compatibility testing with bottles and closures prevents leaching or degradation.

Regulatory Market Readiness

We support compliance for major global markets:
USA (FDA) · EU (EFSA framework) · Southeast Asia · Middle East

Documentation package includes:
COA · MSDS · TDS · Stability Data · Traceability Records

Data Transparency & Full Traceability

Each batch is traceable from raw material origin to finished product.
Digital systems enable rapid audit response and customer verification.

Summary 

Different dosage forms require different risk control strategies.
Our system is built to match each formulation with targeted quality control protocols, ensuring consistency, compliance, and scalable production.