Ze Da Case | Ze Da Instrument Helps Hikvision Biotech Improve the Quality Management Level of Blood Products

In order to fully implement the main responsibility of the holder of the blood product marketing authorization for product quality and safety, strengthen the supervision and management of blood product quality, and comprehensively improve the informationization level of blood product production and inspection, the National Medical Products Administration has revised the appendix of the "Good Manufacturing Practice for Drugs" for blood products and solicited public opinions.

In this context, after several months of rigorous inspection and auditing, Zhejiang Haikang Biological Products Co., Ltd. has reached a cooperation agreement with our company. Our company has installed temperature and humidity recorders and environmental monitoring systems for the cold storage, refrigerator, laboratory, cold chain vehicle, insulated box and other transportation equipment of Hikvision Biotechnology. The project implementation locations include the headquarters production base and multiple single plasma collection stations and raw plasma collection bases within the province, achieving full process traceability of blood products with temperature records. Our company provides computerized system verification services that comply with GMP regulations to ensure that the entire system is quickly put into use.

Zhejiang Haikang Biological Products Co., Ltd. (referred to as Haikang Biological) is a high-tech enterprise in Zhejiang Province that produces blood products. Passed the new version of national drug GMP certification in June 2016. The main products produced include human serum albumin, intravenous human immunoglobulin, hepatitis B human immunoglobulin, and intramuscular human immunoglobulin. Among them, human serum albumin and intravenous human immunoglobulin are high-tech products in Zhejiang Province.