FDA issues warning letter to India's Goran Pharma
- The Food and Drug Administration has sent a warning letter to Goran Pharma in Sihor, India, as a follow-up to an inspection in mid-November 2017, which includes a suggestion that the company bring on board a qualified consultant.
- The letter has identified a number of significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, including a failure to confirm the identity of ingredients; failure to establish quality control; and issues with equipment.
- The FDA placed Goran Pharma on import alert in March, and has informed the company that it may withhold approval of new applications or supplemental applications unless all violations are corrected completely.
Goran Pharma, formed in 1992, manufactures cosmetics, Ayurvedic medicines, as well as prescription and over-the-counter pharmaceuticals. Its pharma clients include Bonita Pharmaceuticals and Cadila Pharmaceuticals.
The company's failings fell into three main areas. It failed to test incoming active pharmaceutical ingredients and excipients as they came in, so could not confirm their identity, purity, and strength. Goran's response, that it would compare results with suppliers' specifications, was deemed inadequate as it was not sufficiently clear. The FDA has requested a detailed description of processes and procedures, a detailed risk assessment, particularly for products containing glycerin, and a comprehensive and independent review of laboratory practices, methods, equipment and analyst competencies.
Goran failed to establish an adequate quality control unit for approval and rejection of components, packaging, materials and products, and released batches without review. The FDA said that the company's standard operating protocol was not sufficient and has required updated processes.
Goran's processing equipment was deemed by the FDA not to be appropriately designed and could foster the development of biofilms. Despite Goran's response over sterilization of a new system, the FDA has requested validation and monitoring plans and procedures, aa well as risk assessments.
And finally, Goran's air handling and control and monitoring of temperature and humidity was not suitable, and the FDA has requested a detailed plan and independent assessment of the facilities and equipment.
In the letter the FDA has recommended the company bring on board a consultant. "The third-party consultant should comprehensively audit your entire operation for cGMP compliance, with special emphasis on the materials, laboratory, facility, and production systems, as well as your overall quality assurance program."
The FDA's Center for Drug Evaluation and Research, the unit that issued Goran's letter, gave out 35% more warning letters in 2017 than in 2016. And an increasing number of those have gone to companies in India; in 2017, 17 of 61 notices went to facilities in India, compared with 10 the year before.
Indian companies have seen a flurry of warning letters so far this yea. Malladi Drugs & Pharmaceuticals was warned about vermin and outdoor API production. Reine Lifescience received a warning about analytical methods, data, and cleaning and maintenance. Keshava Organics was warned about out-of-specification results and record keeping. And Alchymars ICM SM was called out for record-keeping, equipment and building maintenance, and hygiene provision.
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