The quality facilities and operations are located in CAMB Suzhou site which include Quality Assurance (QA) and Quality Control (QC) units responsible for the establishment, implementation, and maintenance/oversight of quality systems governing the services provided by CMAB.
The quality assurance is designed to allow phase appropriate controls across the services provided internally and via qualified third-party contract service providers.
CMAB quality management systems are designed and operated such that a comprehensive single Quality Management System (QMS)is in alignment with Health Authority Requirements and is organized into categories (Management Responsibility, System, Operations, and Enablers) as shown in Figure 1.
A comprehensive documentation control system has been established at CMAB as outlined in the Quality Manual. The document system utilizes a document hierarchy to establish the types in use and clarify the associated functionality as shown in Figure 2 .
This document provides a general description of the quality requirements and responsibilities at CMAB.
these documents provide the corporate requirements ("what") and operational instructions ("how") for major business processes and/or quality elements defined in the governing Quality Policy.
Detail how to execute processes and procedures.
Risk Management files, Work Instructions, Forms, Manufacturing Formula, Specification, Validation document etc.