医药中间体和制剂产品
Search documents
东北制药:全链条质控筑牢发展根基 以质量拓市场创价值
Zhong Guo Zheng Quan Bao· 2025-09-28 22:38
Core Viewpoint - The company emphasizes that quality is the foundation of pharmaceutical enterprises and is focusing on enhancing quality management to drive transformation and upgrade in the context of high-quality development in the pharmaceutical industry [1][5]. Group 1: Quality Management Initiatives - The company is committed to building a comprehensive quality control system that covers the entire supply chain, from raw material procurement to production and product delivery [2]. - A special audit team has been established to conduct in-depth on-site audits of key raw material suppliers across 13 provinces, ensuring stringent quality checks at critical stages [2][3]. - The company has set up a drug safety monitoring department to proactively track and manage product quality issues, transitioning from passive responses to active prevention [3]. Group 2: Compliance and Certifications - The company has successfully passed multiple certifications, including BRC and ISO22000, and its raw material products are exported to over 100 countries and regions [4]. - In the first eight months of the year, the raw material production facility hosted 63 audits from domestic and international clients, achieving a 100% pass rate [4]. Group 3: Cultural and Systematic Quality Focus - The company is fostering a culture of quality among all employees, emphasizing that quality awareness and professional capability are core competitive advantages in quality control [5][6]. - A "simulated flight inspection" mechanism has been established to conduct regular, comprehensive evaluations of production lines, identifying system vulnerabilities and optimizing management processes [6]. - The company aims to enhance its product quality management level and expand both domestic and international markets, laying a solid foundation for its transformation into a biotechnology enterprise [6].
全链条质控筑牢发展根基 以质量拓市场创价值
Zhong Guo Zheng Quan Bao· 2025-09-28 20:45
Core Viewpoint - The company emphasizes the importance of quality as the foundation of its operations and is committed to enhancing its quality management systems to drive market expansion and value creation [1][4]. Group 1: Quality Management Initiatives - The company has established a comprehensive quality control system that spans from raw material procurement to product delivery, ensuring a closed-loop quality management process [1][4]. - A special audit team has been formed to conduct in-depth on-site audits of 25 key raw material suppliers across 13 provinces, focusing on critical aspects such as raw material traceability and production processes [2]. - The company has set up a drug safety monitoring department to proactively track and manage product quality issues, transitioning from a reactive to a proactive approach [2][3]. Group 2: Compliance and Certifications - The company successfully passed a surprise inspection by the FDA with a "zero defect" score, demonstrating its commitment to maintaining high-quality standards [2][3]. - The raw material products have received multiple certifications, including BRC and ISO22000, and are exported to over 100 countries and regions [3]. - The company has achieved a 100% pass rate for audits conducted by domestic and international clients in its raw material production facilities [3]. Group 3: Cultural and Operational Enhancements - The company is fostering a culture of quality among all employees, emphasizing that quality awareness and professional capability are core competitive advantages [3][4]. - A "simulated flight inspection" mechanism has been established to conduct regular internal audits based on GMP standards, identifying system vulnerabilities and optimizing management processes [4]. - The company is committed to a "zero tolerance" policy regarding drug quality, reinforcing the idea that every product must meet the highest standards to ensure public health [4].