Core Competency
Core Competency
Core Competence

Quality Management System

　　Guided by our quality culture philosophy, we have established a high-standard quality management system in compliance with the requirements of the FDA and NMPA. We successfully passed the FDA and National Medical Products Administration (NMPA) GMP audits in August 2019 and June 2020, respectively. As a specialized CMO enterprise under Renfu Pharmaceutical Group, we rigorously adhere to GMP and cGMP regulations and guidelines throughout every stage of product manufacturing. Together with our clients, we continuously optimize process transfer strategies, minimize potential quality risks, and strive to get it right the first time!

　　Quality Policy: Gather the sea of customer satisfaction, build a ship of perfect quality, and hoist the sails of our corporate brand.

　　Quality Vision: Continuously improve the quality system, provide customers with professional quality control strategies, ensure orderly material flow throughout the production process, maintain controllable product quality, clarify work processes, optimize equipment parameters, and ensure thorough personnel training, thereby making the transfer process smooth, clear, and fully manageable.

 

 

　　File System Architecture:

　　Level 1 Document: Quality Manual/Factory Master Document;

　　Secondary Document: Standard Management Procedures;

　　Level 3 Documents: Standard Operating Procedures, Testing Methods;

　　Level 4 Documents: Production Records and Inspection Records.