On April 9, approved by the Market Supervision Administration of Jiangsu Province, the Ninth batch of Local Standards Catalogue of Jiangsu Province in 2020 was officially released. The "Requirements for Quality Risk Control System of Drug Manufacturing Enterprises" (DB32/T 3770-2020) jointly drafted by Yangzijiang Pharmaceutical Group and Shanghai Institute of Quality Management Science was selected and implemented since May 15, 2020, and promoted and applied in the pharmaceutical industry in the province.

The standard specifies the guiding requirements for the construction of quality risk management and control system of drug manufacturers, including: basic concept, leadership and organization, resource allocation, system planning, control process, process application, evaluation and improvement, etc., and comprehensively and systematically expounds the concept and method of drug quality risk management and control. The standard has been declared since 2018, and it has condensed the wisdom of enterprise management practices and standardization industry experts through multiple links such as project establishment, content compilation, soliciting opinions, expert review, revision and approval, and external publicity.

The essential requirement of drug quality is risk control. Combining the long-term quality management practice, Yangzijiang Pharmaceutical draws on the "Golden Circle Rule", applies the international advanced quality risk management concepts and methods, and summarizes the drug quality risk management mode with the mission of "seeking progress and protecting all beings". The model takes "three Nos" as the principle (do not let the patient bear the risk, do not let the risk escalate, do not transfer the risk to other parties), and "four continuous" as the method (continuous questioning, continuous identification, continuous control, continuous review), covering the whole process of drug quality, all elements, and the whole life cycle, and carries out high-standard dynamic management of drug quality risk. Compared with the conventional method, this model increases the "questioning", emphasizes the "persistence", can find the risk more comprehensively and effectively, and has the advanced, unique and extensibility.

In recent years, Yangzijiang Pharmaceutical is committed to promoting high-quality development with standardization construction, participating in the declaration of "International-oriented Chinese medicine overall quality standard system creation and application" won the second prize of National science and Technology Progress, the implementation of "Chinese medicine process intelligent manufacturing National high-tech industry standardization pilot project", and also undertook 15 Chinese medicinal materials "European Pharmacopoeia" plant monographic research work. The quality standards of five varieties have been entered into the European Pharmacopoeia, making a pioneering contribution to the internationalization of Chinese medicine standards.