Introduction to the Quality System
Bostal is committed to the core principles of “Safety, Efficacy, and Controllable Quality” and strictly complies with internationally recognized regulatory requirements, including U.S. 21 CFR Part 210 & 211, EU GMP and its annexes, current Chinese GMP and related appendices, as well as ICH guidelines. The company has established an integrated quality management system covering the entire product lifecycle, including pharmaceutical development, manufacturing, testing, and product release, ensuring full compliance with GMP requirements in China, the United States, and Europe. Guided by the quality philosophy of “Life Supreme, Quality First, and Delivering Better Health for Humanity”, Bostal integrates quality principles throughout every stage of pharmaceutical development and manufacturing.
Built upon GMP requirements as the foundation of its quality management fram
ework, Bostal continuously pursues excellence in quality control and maintains a robust quality management system compliant with global GMP standards and applicable regulatory requirements. The company continuously monitors regulatory updates and optimizes its quality systems, manufacturing processes, analytical procedures, product release processes, and associated operational controls. Bostal has established a dedicated Quality Control Center equipped with advanced analytical instruments and a comprehensive electronic data management system designed to meet data integrity requirements. The company has also developed a professional quality control center consisting of well-trained, qualified, and competency-assessed personnel. Through standardized testing and release review procedures for raw materials, excipients, packaging materials, intermediates, and finished products, Bostal ensures that all analytical data are authentic, accurate, and traceable, thereby maintaining consistent and controllable product quality.
To continuously enhance pharmaceutical quality management capabilities, in addition to complying with domestic and international regulatory requirement on pharmaceutical manufacturing quality management, Bostal has strengthened process oversight and implemented integrated digital management systems, including ERP, QMS, LIMS, PMS, and PQS. Leveraging digital technologies, the company systematically integrates and optimizes key business processes, including pharmaceutical manufacturing, quality control, quality assurance, warehouse and supply chain management, equipment maintenance, and project management. These digital platforms enable compliant operations while significantly improving operational efficiency, transparency, and management excellence.
Bostal is committed to implementing cGMP principles and benchmarking against the highest global pharmaceutical quality standards. Through professional capabilities and efficient service, Bostal strives to support its partners and continuously provide safe, high-quality medicines to patients worldwide.
· China NMPA Inspection History
· U.S. FDA and EU QP Inspection History
