The letter cites lack of adequate quality control measures, recommend hiring a third-party CGMP consultant
Goran Pharma’s Sihor facility in Gujarat has received a US FDA warning letter. Reportedly, deviations from current good manufacturing practices (CGMPs), including failure to identify ingredients from suppliers, inadequate quality control, and inappropriate equipment use, were found at the facility.
The regulatory authority, in its warning letter, has stated that company has lagged in testing components from suppliers and to “determine their conformance to identity, purity, strength, and other appropriate specifications. It says, “Your firm released components for use in drug product manufacturing based on certificates of analysis (COA) from your supplier without establishing the reliability of the suppliers’ analyses through appropriate validation.”
The US FDA has also told the company to provide a detailed plan to ensure that components used in manufacturing be prevented from use until they have undergone adequate testing. The company has also been asked to conduct a comprehensive review of its laboratory practices, methods, equipment, and analyst competencies; adopt risk assessment measures for products manufactured on the old system and enable a detailed validation plan for its new system.
The US regulatory authority has recommended hiring a third-party CGMP consultant to audit and monitor the company’s operations.