Sunshine Guojian Pharma’s Bioreactor Facilities Achieves Mexican GMP License for the Drug Product of YISAIPU

October 12, 2017

[Shanghai, China] Oct 12nd, 2017- Sunshine Guojian Pharma announced today that its bio-manufacturing facilities for the Drug Product of YISAIPU of 3S Group has passed the site inspection of Mexican authorities (COFEPRIS) and achieved the GMP license issued by Mexican government.


During the one-week-long inspection, the inspection officers mainly focused on the company’s Quality Management System, personnel hygiene, material storage and delivery, facilities and equipments, production management, validation & qualification, deviation investigation and change control, manufacturing process, product shipping and recall, document system and etc. The officers’ final positive conclusion and the pass to the inspection once again indicate that Sunshine Guojian Pharma’s production and quality management system has been well recognized by international mainstream practice and global market.


During the one-week-long inspection, the inspection officers mainly focused on the company’s Quality Management System, personnel hygiene, material storage and delivery, facilities and equipments, production management, validation & qualification, deviation investigation and change control, manufacturing process, product shipping and recall, document system and etc. The officers’ final positive conclusion and the pass to the inspection once again indicate that Sunshine Guojian Pharma’s production and quality management system has been well recognized by international mainstream practice and global market.