全链条质量控制
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 20:51
Core Viewpoint - Northeast Pharmaceutical emphasizes quality as the foundation of its business, focusing on enhancing quality management and manufacturing processes to drive market expansion and value creation [1][5]. Group 1: Quality Management Initiatives - The company is committed to building a comprehensive quality control system that spans from raw material procurement to product delivery, enhancing its systematic management capabilities [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 the source [2][3]. - Northeast Pharmaceutical has formed a cross-departmental task force to address changes required by the 2025 edition of the Pharmacopoeia of the People's Republic of China, identifying quality risk points and creating actionable implementation plans [3]. Group 2: Compliance and Certifications - The company has successfully passed multiple certifications, including BRC and ISO22000, and its raw materials are exported to over 100 countries [4]. - In the first eight months of the year, the raw material production facility hosted 63 audits with a 100% pass rate, while the formulation facility also met high standards during inspections by regulatory bodies [4]. Group 3: Cultural and Operational Enhancements - Northeast Pharmaceutical is fostering a quality culture among all employees, emphasizing that quality awareness and professional capability are core competitive advantages [5][6]. - The company has implemented a "simulated flight inspection" mechanism to regularly assess production lines against GMP standards, identifying and addressing potential weaknesses in the quality management system [6]. - The commitment to quality is ingrained in the company's culture, with a focus on maintaining a "zero tolerance" approach to quality control, ensuring that every product meets the highest standards [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].