On October 12, 2017, Sunshine Guojian’s YISAIPU was successfully granted the GMP certificate issued by the Mexican Ministry of Health.
Before then, the GMP comptrollers of the Mexican Federal Committee for Protection from Sanitary Risks (COFEPRIS) visited the entrusted processing and production base of YISAIPU by 3SBio Group, or Sunshine Guojian Pharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as “Sunshine Guojian”), for a one-week on-site inspection of GMP compliance. The comptrollers comprehensively and strictly implemented the on-site inspection, employee enquiry, information query and confirmation 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 Mexico’s current GMP rules and regulations. The approval of this certification not only highly affirms Sunshine Guojian’s production quality management, but also marks that the production quality management system in the Shanghai biological drug production base of 3SBio Group has gradually moved in line with international standards.
In view of the influence of Mexico in the whole Latin America region, this GMP certification will positively promote sales of YISAIPU in Mexico, which is of great significance to expand its Latin American market, and also lays a new and important milestone for the company’s product line to enter a broader international market.