CSPC Receives Another Japanese GMP Certificate

April 30, 2024

Recently, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (hereinafter referred to as "Zhongnuo Shijiazhuang") received the GMP Compliance Inspection Result Notification issued by Japan's PMDA (Pharmaceuticals and Medical Devices Agency) for the sterile meropenem product. This certificate represents the sixth Japanese GMP certificate for CSPC and the first Japanese GMP certificate for CSPC for sterile APIs.

Japanese GMP certification is one of the authoritative certifications in the field of international pharmaceutical manufacturing. Since Zhongnuo Shijiazhuang received the notice of on-site inspection from the competent authority in August 2023, all the functional departments and workshops have worked together to conduct a comprehensive review of the material system, production system, quality system, laboratory control system, facility and equipment system, packaging and labeling system and related supporting hardware and supporting documents, formulating a strict and detailed improvement plan as well as arranging special personnel to be responsible for ensuring the implementation of measures.

The prevention and management of cross-contamination and the daily monitoring of trace antibiotics are always key inspection items of PMDA. On the basis of continuously improving cross-contamination prevention management and monitoring methods, Zhongnuo Shijiazhuang proactively referred to Japan's GMP regulations and communicated with experts several times to enhance the Company's ability to prevent and manage cross-contamination in multiple dimensions. In order to adapt to the international inspection, Zhongnuo Shijiazhuang seized the opportunity of this PMDA inspection to gradually complete the bilingual updating of inspection reception layout plans of various departments and put them into practice during this inspection.

In December 2023, inspectors from the Pharmaceutical Quality Management Department of PMDA began a 4-day on-site inspection of GMP compliance for the Company's sterile meropenem. Zhongnuo Shijiazhuang demonstrated its capabilities of efficient production management and strict quality control, and was highly recognized by inspectors.

CSPC has long been highly focused on the development of the high-standard quality system, and has made continuous efforts to achieve the most advanced international quality standards. The Group has successively obtained 6 Japanese GMP certificates, 13 CEP certificates, and 25 DMF registration numbers, with 25 products passing the on-site inspection by the US FDA. The success of this Japanese GMP certification is the critical permit for CSPC's sterile meropenem product to enter the Japanese market and creates favorable conditions for the product to take a place in the high-end market. It also marks that the Company's quality management system maintains the international leading level.

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