SUPERVISORY MANAGEMENT
Quality Management
Changchun Beacon Biotechnology Co., Ltd. has established a Quality Manual in accordance with ISO 9000 and ICH Q10, clearly defining the quality policy and formulating quality objectives aligned with that policy. The quality management system is organized into six major subsystems: Personnel Management System, Facilities and Equipment Management System, Materials Management System, Laboratory Management System, Quality Assurance Management System, and Production Management System. Within each subsystem, the key elements of GMP are described in detail, and corresponding procedural documents have been developed to ensure control over the entire product lifecycle—from design and development and the clinical phase through to manufacturing, storage, sales, and after-sales service. Through quality operational practices such as deviation management, CAPA management, change control management, quality risk management, and self-inspections, the company continuously promotes the ongoing improvement of its quality management system, thereby ensuring the safety, efficacy, and controllability of product quality.
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