Mabridge Quality Management System Profile

Focused on CDMO business, Mabridge has established a comprehensive quality system that complies with the requirements of FDA, EMA and NMPA. The system is based on ISO 9001, supplemented by ICH Q10, and detailed by GMP covering the entire life cycle of drug product, includes process development, technology transfer and commercial manufacturing.
Through the implementation of advanced computerized systems such as SAP, QMS and LIMS to realize lean and compliant enterprise management and quality management.
The company has established an independent quality management department. Head of quality and head of production are independent of each other within the reasonable organization structure. The company has established a relatively complete three-level training system, and key positions are held by technical experts with qualifications and rich experience.
QC laboratory is equipped with advanced imported instruments with comprehansive testing capbilities of raw materials, environmental monitroing, intermediates, biological products; efficient and professional team; clear and standardized management procedures that comply with NMPA, EU, and FDA regulatory requirements.

The company has established a warehousing system for materials and products, including a material incoming inspection and release system, a supplier audit system, a product release system, a quality complaint system and a cold chain transportation system to ensure that the quality of products is always under control from the starting raw materials to final products.
The company has established a facility and equipment maintenance system, and the instruments/equipment has been calibrated, validated or qualified to ensure that it meets the requirements of GMP.
The company has established a system of deviation, change control, corrective actions and preventive actions as well as internal audit, management review, annual product quality review and quality risk management. For contract research and manufacturing, a system for client’s intellectual property protection has also been established.
The quality system is reviewed and maintained by the QA department on a regular or irregular basis to ensure continuing effectiveness.
Mabridge welcomes all clients at home and abroad to visit, audit and guide.