Big news! Enzalutamide API successfully passed FDA on-site audit

From August 21 to 25, 2023, the U.S. Food and Drug Administration (FDA) conducted a five-day on-site audit of Qingfeng Pharmaceutical's enzalutamide API and the company's overall production quality management system. FDA Inspector Ms. Michele Glendenning gave a formal opinion that the inspection passed.

Enzalutamide is the first product that Qingfeng Pharmaceuticals applied for registration with the U.S. FDA, and this audit is also the first time that Qingfeng Pharmaceuticals has faced an FDA audit. The successful passing of this audit laid the foundation for enzalutamide to be approved for marketing in the United States. It also marked a critical and substantial step taken by Qingfeng on the road to internationalization, which is a major milestone.

During the audit, the FDA inspectors conducted a detailed inspection of the process, equipment, environment, warehouse, quality inspection instruments, annual review reports, changes, deviations and other documents, focusing on a comprehensive assessment of the consistency of the application materials, the integrity of the quality system, the reliability of the data, etc. At the final meeting held on the afternoon of the 25th, the FDA inspectors gave a formal opinion that the inspection had passed.

Since its establishment, Qingfeng Pharmaceutical has adhered to the corporate mission of " Providing sustainable and high-quality service for human health ". It has always regarded product quality as the lifeline of the enterprise, adhered to bottom-line thinking, insisted on quality first, and focused on system construction and process control.

Since its establishment, Qingfeng Pharmaceutical has adhered to the corporate mission of " Providing sustainable and high-quality service for human health ". It has always regarded product quality as the lifeline of the enterprise, adhered to bottom-line thinking, insisted on quality first, and focused on system construction and process control.

In recent years, the company has actively benchmarked against regulatory requirements such as the FDA, referred to guidelines such as ICH, and based on the quality management requirements of the product's entire life cycle, from the research and development stage to the GMP implementation stage of production management (supplier management, production management, quality control, risk management, product release, etc.), and then to product promotion, clinical application and drug vigilance. We are committed to establishing an efficient, compliant, complete and internationally compliant quality management system, strictly controlling each product quality checkpoint to ensure the safety and compliance of drugs.

Accepting FDA audits is an important way for Qingfeng Pharmaceutical to enhance its core competitiveness and market recognition, improve its own quality management level, and is an important channel for Qingfeng to move towards internationalization. Qingfeng Pharmaceutical will take this FDA audit of Enzalutamide as an opportunity to carefully summarize experience, comprehensively and continuously improve the company's quality management level, and strive to provide high-quality drugs and services to patients around the world.