Pharmaceutical Quality Risk Control Mode with the Purpose of "Dedicated to Exploring and Advancing, Committed to Caring for All"

质量风险管控图

YRPG's pharmaceutical quality risk control mode emphasizes that risk management is the essence of pharmaceutical quality. Ensuring that drug quality risks are controllable is a pharmaceutical company's utmost responsibility.

YRPG inspires and motivates employees and influences stakeholders with the purpose of “Dedicated to exploring and advancing, committed to caring for all” Quality is ingrained into our hearts, and we take firm control of risks. We define "how to do" and "what to do." From the inside out, we established a drug quality and risk control mode centered on the "Three Never Principles" and the "Four Continuous Methods," ensuring high-standard dynamic management of drug quality risks. The mode diagram is shaped like a steering wheel, indicating the direction with advanced concepts that are safe and controllable, forming a closed loop.

  • The "Three Never Principles" are to never let patients bear risk, never allow risk to escalate, and never transfer risk to others. This outlines "how to do".

  • The "Four Continuous Methods" are continuous questioning, continuous identification, continuous control, and continuous review. These outlines "what to do."

In April 2020, the Requirements for the Quality Risk Control System of Pharmaceutical Manufacturing Enterprises (DB32/T3770-2020), drafted based on this mode, was approved as a local standard in Jiangsu Province and has been promoted for application across the province's quality industry since May 2020. In August 2022, the relevant management experience of the mode was compiled into a book titled Making Medicines by Considering Customers as Our Parents and Loved Ones: The Pharmaceutical Quality Risk Control Mode of Yangtze River Pharmaceutical Group, which was officially published by China Standard Press and included in the series Best Practices of Quality Management in China in the 21st-century, contributing "Yangtze River Wisdom" to industry development. In March 2024, the Group Standard Requirements and Implementation Guide for the Quality Risk Control System of Pharmaceutical Manufacturing Enterprises (T/CQAP 4001—2024), under the jurisdiction of the China Pharmaceutical Quality Management Association and jointly led and drafted by YRPG, was officially released.

Making Medicines by Considering Customers as Our Parents and Loved Ones: The Pharmaceutical Quality Risk Control Mode of Yangtze River Pharmaceutical Group

Requirements and Implementation Guide for the Quality Risk Control System of Pharmaceutical Manufacturing Enterprises (T/CQAP 4001—2024)

Requirements for the Quality Risk Control System of Pharmaceutical Manufacturing Enterprises (DB32/T3770-2020)

Quality Management Mode