World regulators are cautious about crude heparin after China-made APIs were responsible for dozens of deaths in the U.S. more than a decade ago. Now, European regulators are banning heparin from a Chinese facility after finding contamination risks.
Italian inspectors recommended the European Medicines Agency pull the manufacturing approval for and ban the heparin from Yibin Lihao Bio-technology after they found significant issues at its facility in Yibin, Sichuan, China, during an October inspection.
There are few details in the report the EMA posted to its EudraGMDP site, but it said investigators found two dozen violations, seven of them major, at the maker of crude heparin, an anticoagulant. Those included risk of contamination, unsatisfactory traceability of starting material, poor materials management and recovery of solvents as well as issues with buildings, facilities, equipment and storage.
Two years ago, French regulators recalled heparin after finding Chinese company Dongying Tiandong Pharmaceutical in Shandong province had manipulated tests of crude heparin supplies that had showed the presence of ruminant DNA. It said there was no evidence that the samples used to perform retesting came from the same batches that showed the ruminant.
GMP rules require heparin be manufactured only from pig intestines, because when “ruminant” animals like cattle are used there is a chance the raw material could be contaminated with bovine spongiform encephalopathy or oversulfated chondroitin sulfate (OSCS), a cheap filler product that saves money but can be deadly to patients. In 2008, heparin contaminated with OSCS was tied to the deaths of 80 dialysis patients in the U.S.
Nov 29, 2018