On April 1, 2017, the 30,000L Antibody Production Line Preparation Zone III of Sunshine Guojian Pharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as Sunshine Guojian) was granted the “Certificate of Good Manufacturing Product for Pharmaceutical Products” (Certificate No.: SH20170009, valid until March 2022) by the China Food and Drug Administration.
The 30,000L antibody production line includes two stock solution production lines and one preparation production line, which is the largest monoclonal antibody production line in China at present, and is also one of complete production lines with the production capacity from stock solution to preparation (multiple dosage forms and specifications) around the world. The whole process covering design, construction, commissioning, validation, verification, trial production and mass production of the complete production line was strictly implemented in accordance with the GMP standards of the United States, the European Union and China. The Preparation Zone III has the production capacity of complete preparation from semi-finished product preparation, aseptic filtration, cork processing, partial corking in subpackaging, freeze-dried corking to capping, and is equipped with high-speed penicillin bottle filling line and freeze dryer with leading technologies in the world, which can satisfy the production of various preparation specifications of sterile liquid injection and freeze-dried powder injection from 2ml to 50ml, with a filling speed reaching 300 bottles/minute and an annual production capacity of up to 4.5 million bottles of freeze-dried preparations. The production operation in the Preparation Zone III has been highly automated, with complete process control technology and online environmental monitoring system, so as to minimize the risk of contamination and fully meet the production requirements of sterile products.
On December 20-23, 2016, the expert group for on-site inspection and acceptance of GMP for pharmaceutical products organized by the Center for GMP Certification and evalsuation of provincial food and drug administration bureau authorized by the China Food and Drug Administration conducted a comprehensive review and inspection on the implementation of new-version GMP by Sunshine Guojian. During the review, the expert group implemented the assessment and evalsuation 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 line with the principle of openness, justice and fairness and strictly referring to the provisions in the “Good Manufacture Practice of Medical Products”(Rev. 2010). The experts fully grasped the actual conditions of each item under inspection through briefing, information access, site inspection, collective questioning, individual spot inspection and other forms, to ensure that an objective, true and accurate evalsuation conclusion was obtained. After the 4-day intensive work, the expert group unanimously agreed that the company’s Preparation Zone III in the 30,000L Antibody Production Line was fully in line with the requirements of new-version GMP, marking it successfully passed on-site inspection and acceptance review.
The granting of new-version GMP certificate to the Preparation Zone III of the 30,000L Antibody Production Line marks that the 30,000L project designed, built and run on a trial basis by Sunshine Guojian in accordance with the European Union standards has been recognized by the national drug regulatory authority. So far, the company has two GMP certified preparation production lines, which ensures and expands the group’ product capacity of YISAIPU. It also showed that the Preparation Zone III of the 30,000L Antibody Production Line could be formally put into commercial production, which provides more substantial technical and capability guarantee for the production of the company’s subsequent new products.