Runyi New Material has established an end-to-end quality traceability system covering everything from raw material receiving to finished product release. Strictly adhering to internationally recognized quality management standards, we are committed to delivering stable, reliable, and compliant high-quality products to our customers.

Quality Control Workflow:

Supplier Qualification In-Process Testing Full-Spec Testing Batch Record Review COA Attached

System Alignment:

●ISO 9001: Quality Management System (planned)

●cGMP: Current Good Manufacturing Practice (actively aligning)

●ICH Q7: GMP Guide for Active Pharmaceutical Ingredients (actively aligning)

Quality Capability Highlights:

●Full Traceability: Each batch can be traced back to raw material source, production records, and test data.

●In-Process Control: Critical process parameters (temperature, pressure, pH, etc.) are monitored in real time with instant alerts for abnormalities.

●Testing Capability: Equipped with advanced analytical instruments such as HPLC, GC, and GC-MS, supporting full-spec testing.

●Documentation Management: Standardized preparation of batch production records, test reports, and deviation investigation reports, ensuring data integrity.

Quality Commitment:

●Each batch comes with a COA (Certificate of Analysis).

●MSDS (Material Safety Data Sheet) available upon request.

●Customer on-site audits and third-party testing supported.

R&D and Manufacturing: Integrated Synergy

Runyi New Material deeply integrates R&D and manufacturing, forming a complete closed loop from process development to large-scale production:

Lab Route Development Technical Breakthrough Process Package Delivery Stable Supply

●R&D provides mature, green, and cost-effective process routes for manufacturing.

●Manufacturing provides industrialization feedback to R&D, continuously optimizing processes and costs.

●Quality is embedded throughout the entire process, ensuring stable, reliable, and compliant product delivery.

Driven by the dual engines of "Technological Innovation + Lean Manufacturing," we provide our customers with one-stop solutions from R&D to commercialization.