From October 9th to 12th, Center for Food and Drug Inspection of NMPA dispatched 4 inspectors to conduct on-site inspection of the registration of Compound Glycyrrhizin Tablets at Jiudian Pharmaceutical.

Compound Glycyrrhizin Tablets is a product held by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd. and entrusted to Jiudian Pharmaceutical for production. The inspection team conducted a comprehensive and detailed inspection on the feasibility of commercial production of Compound Glycyrrhizin Tablets, technology transfer, data reliability, quality control, and communication and connection between the commissioning and the commissioning parties in accordance with the "Drug Registration Management Measures" and "Drug Production Quality Management Standards" and other laws and regulations. The inspector fully recognized our company's quality management system, announced that the inspection was successfully passed, and made valuable suggestions on GMP data management. The inspector is rigorous, meticulous, responsible, and knowledgeable in GMP management. During the communication process, them pointed out the key points of the problem, so that colleagues involved in the communication can deeply understand and accurately grasp the direction of improvement.

Before the on-site inspection of the registration, the Document QA Office organized all departments of the production center to conduct self-inspection and self-correction of documents and on-site inspections, and conducted comprehensive self-inspections around compliance, data integrity, reliability, etc., and focused on the consistency of the production and quality control documents of Compound Glycyrrhizic Acid Tablets with the application materials, the production conditions of the fifteenth workshop, the communication and connection between the trustee and the holder, and the technology transfer with the R&D party. After the inspection, all departments of the company immediately held an analysis and discussion meeting on the defects and suggestions raised by the inspectors, and formulated rectification and preventive measures.

The company successfully passed the inspection, indicating that the current quality management system meets the company's actual and CMO production requirements and can operate effectively, which is conducive to the further development of the company's CMO business.