Since December 6, 2024, Foshan RuiTong Consulting Co., Ltd. (hereafter referred to as RuiTong) has dedicated ourselves to assisting a pharmaceutical company in Xuchang, Henan to address the deficiencies raised by the inspection conducted by the unannounced inspection team of NMPA, and to assisting this company to submit rectification report for unannounced inspection deficiencies to NMPA at the end of December, 2024. After several months of persistent efforts, this company passed GMP compliance inspection conducted by Henan medical products administration on March 09, 2025.

In dealing with the issues raised by the unannounced inspection of NMPA, RuiTong established a specialized team and visited the production site of the pharmaceutical company in-depth. Based on the requirements of GMP and relevant laws and regulations, RuiTong thoroughly reviewed the deficiencies exposed during the unannounced inspection, covering aspects such as production environment, equipment and facilities, staff management, document records, and quality management systems.

During the rectification process, RuiTong collaborated closely with the pharmaceutical company to formulate detailed and targeted rectification schedule. For issues related to production environment, suggestions were made to optimize workshop layout and strengthen cleaning and disinfection procedures; for equipment and facilities, assistance was provided in establishing maintenance schedule and operation procedures; for staff management, professional training was organized to improve quality consciousness and operation skills; for document records, guidance was given on setting up a standardized and comprehensive file management system to ensure accuracy and traceability; at the quality management system level, support was provided to optimize internal audits and management reviews, strengthening quality risk prevention capabilities.

After three months of persistent efforts, significant rectification achievements were realized. During the GMP on-site inspection conducted by Henan medical products administration on March 2025, the company's improvement outcomes in various aspects received high praise from the inspection team, the company successfully passed the inspection. This achievement not only demonstrates the professional capabilities and extensive experience of RuiTong in the field of pharmaceutical consulting services but also lays a solid foundation for the ongoing compliance production and development of this pharmaceutical company in Xuchang, Henan. In the future, RuiTong will continue to leverage our expertise to assist more pharmaceutical companies enhance their quality management systems, ensuring product safety, efficacy, and controllability.

RuiTong always adheres to the philosophy of “Customer-Centered, Results-Oriented”, treat customers as one’s own matters, help customer to solve problems and improve their quality management levels and competitive capabilities. If inquiries about our GMP and drug registration (CEP/DMF/ASMF/PQ) services, please feel free to contact us.

Foshan RuiTong Consulting Co., Ltd.

Room 803, Fuwei Building, Huangqi GuangFo Road 1, Dali Town, Nanhai District, Foshan City, Guangdong Province, 528248, China

Website: http://www.gdruitong.cn/

Tel: +86-13660057841, +8613695153512

E-mail: ruitong01@gdruitong.cn