Quality Systems

Quality Compliance

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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 .

The document types include:
  • Level 1

    Quality Manual (QM):

    This document provides a general description of the quality requirements and responsibilities at CMAB.

  • Level 2

    Quality Policy (POL):

    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.

  • Level 3

    Standard Operation Procedure(SOP):

    Detail how to execute processes and procedures.

  • Level 4

    Risk Management files, Work Instructions, Forms, Manufacturing Formula, Specification, Validation document etc.

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