From May 7th to 10th, after strict inspection by the expert group of the Drug Evaluation Center of the National Medical Products Administration, the new variety declared by our company successfully passed the on-site verification of drug registration and GMP compliance review. This marks a new level in the construction of our company's quality management system for raw material drug production, laying a solid foundation for the subsequent product launch.
This inspection lasted for four days, and the expert group conducted a comprehensive and detailed evaluation of our company's quality management system for the production of new varieties through various forms such as on-site inspection, document review, and personnel interviews. Key aspects such as production process, quality control, equipment and facilities, and document management were thoroughly inspected. The expert group fully recognizes our company's improved quality management system, standardized production operation procedures, and rigorous quality control measures, especially in the areas of process validation, analysis method validation, and other work achievements.
As an important cardiovascular emergency drug, the quality of the raw material of the new variety directly affects the safety and effectiveness of the formulated product. Since the launch of our new product development project, our company has always adhered to the principle of "quality first" and strictly carried out research and production work in accordance with domestic and foreign regulations such as the Chinese Pharmacopoeia and ICH guidelines. By forming a professional technical team, investing in advanced research and development equipment, and establishing a comprehensive quality control system, we ensure that the entire process of product development and production strictly complies with GMP requirements.
The successful passing of this inspection is not only a recognition of our company's quality management level, but also a recognition of our corporate spirit of continuous improvement and pursuit of excellence. We will take this as an opportunity to continue adhering to the concept of "quality comes from design", continuously improve our quality management level, and build our company into a professional and high-quality supplier of active pharmaceutical ingredients.
In the future, our company will continue to increase investment in the field of active pharmaceutical ingredients, improve our quality management system, enhance our technological innovation capabilities, and strive to continuously move towards a high standard active pharmaceutical enterprise that integrates research and development, pilot testing, production, sales, and technical services.