Overheated drug risk at Indian site, US FDA issues warning
The US Food and Drug Administration (FDA) issued the letter following an inspection at the drugmakers manufacturing facility in Gujarat, India from November 13-15, 2017.
According to the FDA, Goran Pharma Pvt Ltd did not control nor monitor temperature and humidity in its manufacturing and warehouse areas.
“You confirmed that your drug products may be exposed to temperatures over 30°C (86°F) and that temperatures in your facility can reach 50°C (122°F) during hot weather months,” said the FDA.
Equipment for adequate control over air pressure, micro-organisms, dust, humidity was also lacking, said the Agency, explaining that this could adversely affect the quality of the firm’s raw and in-process materials, as well as its finished products.
The FDA also flagged identity, purity and strength issues for active ingredients and excipients sourced from suppliers.
“For example, your firm did not test each lot of glycerine used as a component of your drugs to determine whether diethylene glycol (DEG) or ethylene glycol (EG) was present.
“DEG contamination in pharmaceuticals has resulted in various lethal poisoning incidents in humans worldwide,” said the Agency.
According to the letter, ‘appropriately designed’ equipment in the manufacture, process, packaging, or holding of drug products was also deficient: “The system, which you indicated was ‘sterilised’ contained piping with dead legs [a one-way water system]. This inappropriate system design fosters the development of biofilms.”
The Agency placed the firm on Import Alert 66-40 in March this year and has ‘strongly recommended’ that Goran Pharma hire a consultant to address the good manufacturing practice (GMP) violations.
