Since July 17, 2017, Sunshine Guojian Pharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as “Sunshine Guojian”) accepted the 5-day comprehensive GMP inspection conducted by the National Food and Drug Administration of Colombia. The review results showed that Sunshine Guojian’s Stock Solution Zone A, Stock Solution B, Preparation Zone I and Preparation Zone III of Antibody Production Lines passed the official GMP certification review in Columbia.
The review scope included all production lines at Sunshine Guojian. During the review, Colombia officially appointed three comptrollers to implement the inspection and assessment with regard to the company’s quality management system, personnel, health, material storage and distribution, plant facilities, production management, verification and validation, investigation and treatment for deviation and change, production technology, product delivery and recall, file system, in accordance with the provisions of China and Colombia’s drug production quality management specifications and referring to the requirements of European and US GMP regulations. The inspection team had a unique perspective and put forward many practical suggestions during the inspection.
In particular, this inspection could be passed only after completing and closing all issues discovered during the inspection. During this period, all colleagues of the company’s production quality team and the group’s overseas registration and sales teams were fully prepared and dedicated to the inspection. After accompanying the inspection during working hours each day, they also participated in a summary meeting to analyze and deploy the solutions for rectification items. For the issues discovered in the inspection, the functional teams of all departments cooperated actively, took the initiative to assume responsibilities, responded promptly and implemented rectification measures properly, which showed the excellent team spirit and style of fighting!
After one-week professional and intensive work, the inspection team unanimously agreed that Sunshine Guojian’s antibody production lines were fully in line with the requirements of GMP certification in Colombia, marking it successfully passed the on-site inspection. It is the 3rd consecutive time that the company has passed the certification review since the company first obtained the official GMP certification in Colombia in 2006.
Colombia is one of the most important overseas markets for Sunshine Guojian’s YISAIPU. Passing the official GMP review in Colombia this time marked that Sunshine Guojian’s production quality system is recognized by domestic and overseas markets and authoritative regulators once again. It also lays a foundation for the continuous and stable growth of the overseas sales of YISAIPU, and provides more confidence and stronger technical guarantee for the company to expand in the overseas markets.