From February 9 to 10, 2023, the audit experts of Novartis conducted a two-day on-site audit of the GMP quality system of Chuancheng Pharmaceutical. Yang Qingkun, the company's commercial director, and Chen Xiumei, the quality director, were accompanied throughout the whole process.
At the first meeting, experts had a comprehensive understanding of the overall situation of Chuancheng Pharmaceutical and the implementation of the GMP quality system.
Subsequently, the experts carried out a comprehensive and in-depth on-site inspection of the company's warehouses, laboratories, production plants, equipment and facilities, and a detailed review of the company's GMP system documents, especially in-depth communication and guidance on quality management work such as change control, deviation handling, OOS management, supplier management, data integrity, release management, personnel training, etc.
At the closing meeting, experts highly affirmed the quality system documents, laboratory hardware construction and other overall conditions of Chuancheng Pharmaceutical, and put forward guiding opinions and suggestions.
Novartis has a diversified business portfolio, covering innovative patented drugs, ophthalmic health care, non-patented drugs, consumer health care, vaccines and diagnostics, and is a world leader in all fields. Through this audit, Chuancheng Pharmaceutical has a deeper understanding and understanding of FDA's on-site inspection, and has played a role in promoting the overall improvement of the company's quality system. Chuancheng Pharmaceutical will take this quality audit as an opportunity to further strengthen the quality management of the enterprise, make the enterprise bigger and stronger, and achieve more extensive and in-depth cooperation with more well-known pharmaceutical enterprises at home and abroad.