Since the implementation of the new Drug Administration Law, a number of drug marketing authorization holder (MAH, Type B Certificate) enterprises have emerged in China. To further implement the main responsibility of MAHs for quality and strengthen the supervision and management of the entrusted/contract manufacturing links of drugs, the National Medical Products Administration (NMPA) successively issued the Announcement on Strengthening the Supervision and Management of Entrusted Production by Drug Marketing Authorization Holders in October 2023 and the Announcement on Strengthening the Supervision and Management of Contract Manufacturing of Drugs (Draft for Comments) in November 2024.

In order to implement the relevant national drug supervision requirements, from August 27 to 29, a total of 3 inspectors dispatched by the Fujian Provincial Drug Administration and the Hunan Provincial Drug Administration visited Jiudian Pharmaceutical's Production Center to conduct a pre-marketing GMP compliance inspection on the commercial production of Cetirizine Hydrochloride Drops entrusted to Jiudian Pharmaceutical by Fujian Dapu Biomedical Co., Ltd.

Before the inspection, the Document QA Office of Jiudian Pharmaceutical's Production Center organized various departments to conduct document and on-site self-inspections, and promptly rectified potential problems to ensure that the company was in the best condition to meet the inspection. During the inspection, in strict accordance with laws and regulations such as the Good Manufacturing Practice for Drugs (revised in 2010), the inspectors conducted a comprehensive inspection covering aspects including product process consistency, workshops and equipment, organizations and personnel, material management, production management, packaging and labeling management, qualification and validation management, as well as quality assurance and quality control. Among these, the consistency of production processes, the consistency of document implementation, the risk assessment of shared production lines in workshops, and the product cleaning validation were the key focus areas. All departments of the company fully cooperated throughout the inspection process, providing strong support for the smooth progress of the inspection.

At the closing meeting, the inspectors affirmed the compliance of Jiudian Pharmaceutical's production management and quality management, and announced that no critical defects or major defects were found during the inspection, and the inspection was successfully passed.

The successful passing of this inspection is not only a recognition of Jiudian Pharmaceutical's past work, but also an encouragement for its future development. Taking this inspection as an opportunity, the company will further improve its quality management level and CMO business management level, efficiently complete various tasks, and contribute to drug production.