From November 5th to 8th, the Hunan Provincial Drug Administration dispatched three inspectors to conduct a four-day GMP compliance inspection on Jiudian Production Center in strict accordance with the requirements of the Good Manufacturing Practice for Pharmaceuticals (revised in 2010) and other laws and regulations. The inspection scope covered the workshops for granules, oral dry suspensions, oral solution, and tablets.

During the inspection, the inspectors conducted a detailed inspection of the process consistency, quality management system, supplier changes, and production site change research of granules, dry suspensions, oral solution, and tablets  by cross-checking on-site inspections and document reviews. The inspectors affirmed Jiudian's quality management system, and at the same time put forward suggestions for the company's production and quality management to be improved, focus on changing control and electronic data management of production equipments, hoping that Jiudian can play a leading role in various GMP activities.

Before this inspection, the Document QA Office of Jiudian Production Center organized personnel from relevant departments to conduct on-site self-inspections and document self-inspections of production workshops, public systems, logistics departments, and QC laboratories, and reviewed documents in various aspects such as material management, process documents, confirmation and verification, and production management, and promptly fed back to various departments for rectification. During the inspection, all departments cooperated highly and actively answered questions raised by the inspectors. After the inspection, each department immediately held an analysis and discussion meeting on the defects and suggestions raised by the inspectors, and formulated corresponding corrective and preventive measures.

It is worth mentioning that this inspection is the first GMP compliance inspection after the expiration of the GMP certificate of the fifteenth workshop, and it is also the GMP compliance inspection of the newly added production site of a certain tablet The inspection results show that Jiudian Production Center has no serious defects and major defects and passed the inspection smoothly. In the future, the company will continue to improve the production and quality management system, strive to enhance the competitiveness of the industry, and contribute to the healthy development of my country's pharmaceutical production field.