CHENNAI: The officials of the Tamil Nadu Drug Control department, who inspected the Global Pharma Healthcare Ltd company in Chennai along with a team from the Central government, on Tuesday said there is “no contamination” in eye drops exported to the US.
The inspection was conducted days after adverse events including deaths were reported in the US. The US Food and Drug Administration (FDA) flagged the issue in February.
Speaking to TNIE, PV Vijayalakshmi, director, TN Drug Control said, “We tested raw materials and also the same batch samples, and no contamination was found. They are of standard quality. But, only sample testing is over and inspection is continuing. We are checking other parameters, including manufacturing process among other things, “ Vijayalakshmi said.
FDA flags issues
After several rounds of inspection, the FDA in its report had said the accuracy sensitivity, specificity, and reproducibility of the test methods have not been established. Equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use, the report said.
“Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room. Your firm failed to conduct at least one test to verify the identity of each component, of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analysers at appropriate intervals, “the report said.
Drug product production and control records are not reviewed and approved by the quality control unit to determine compliance with all established, approved return procedures before a batch is released or distributed. The quality control unit lacks the responsibility and authority to approve, and reject all components, drug product containers, closures, in-process materials, packaging material, labelling, and drug products, the report said.