The Food and Drug Administration (FDA) is a federal government agency responsible for regulating and approving the safety and efficacy of food, drugs, cosmetics, medical devices, and other products. The FDA is widely recognized as one of the most authoritative and rigorous institutions for global drug quality regulation. Passing FDA certification means that the product has undergone rigorous review and testing, meets FDA standards and requirements, and is more easily recognized and accepted in the international market, thereby obtaining the "world pass" of the pharmaceutical industry and laying a solid foundation for the product to enter the high-end markets of Europe and America.

Challenges/initial situation/customer objectives 

From June 20th to 28th, Yangtze River Pharmaceutical Group Co., Ltd. underwent on-site inspections of cGMP (current Good Manufacturing Practice) by the US Food and Drug Administration (FDA). A team from the US FDA inspection team conducted a 9-day pre registration cGMP certification inspection on the company's sterile product - esomeprazole sodium for injection.

Solution/portfolio

The entire system adopts a wireless and wired architecture for implementation and stable operation.

With unique transmission stability and data redundancy, it ensures data integrity in catastrophic situations, scalable architecture, and excellent system performance, providing a strong foundation for cost reduction, efficiency improvement, stable operation, and convenient and rapid implementation of later supplementary monitoring point construction, installation, and verification.

Benefits/value to customer

This cGMP certification project is the first time that Yangtze River Pharmaceutical Group Co., Ltd. has received on-site inspections from the US FDA, and it is also a key link in the ANDA generic drug application review process for the esomeprazole sodium injection project. At the final meeting, the inspector announced the inspection results of PAI (Pre Registration Approval Inspection Plan) in key areas such as laboratories, where continuous monitoring of refrigerators and incubators is also a key area for inspection. It is recommended to approve. This marks that Yangtze River Pharmaceutical's cGMP quality management system has been recognized by international authoritative drug regulatory agencies, which is a milestone for the internationalization of the enterprise.