Indian Pharma Firms Build FDA-Approved Oncology Plants Following IQ, OQ, PQ Protocols Under GMP Standards
Indian pharmaceutical companies are increasingly establishing FDA-approved oncology manufacturing plants to meet stringent US and EU regulatory standards. These facilities require advanced containment, cleanroom design, and rigorous validation processes including IQ, OQ, and PQ protocols to ensure compliance with international GMP standards. The approval process involves multiple regulatory steps such as state licensing, CDSCO approval, and FDA registration, often taking two to three years from planning to inspection. Companies must invest heavily in infrastructure, staff training, data integrity, and quality systems to avoid FDA inspectional observations under the Food, Drug, and Cosmetic Act. Successful FDA approval grants access to lucrative global oncology markets, reflecting significant commercial and credibility benefits. The development of such plants represents a strategic shift beyond generic drug manufacturing, emphasizing long-term compliance and quality to support the expanding global oncology drug market.