cGMPs / QRM Process

More China Infant Deaths; Vaccine Producers Fail to Get GMP Certification


Jan 02, 2014

Chinese Health Authorities have reported two additional infant deaths, following Hep B vaccines from the Dalian Hissen Bio-Pharm Inc.

This brings the infant death total to 11, with three different vaccine producers - Kangtai Biological Products, Beijing Tiantan Biological Products, and Dalian Hissen Bio-Pharm - implicated in the investigation.

According to the Global Times, the China Food and Drug Administration did not include the three aforementioned companies on its most updated list of companies that have received the Good Manufacturing Practices certificate for pharmaceutical products. This means that China's top three producers of hepatitis B vaccines are banned from manufacturing new products in 2014, which may cause a shortage in the market.