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Quality System

The implementation and maintenance of an effective quality management system is the foundation of global compliance. QuaCell believes that high-quality raw material quality and supply chain management are the cornerstones of high-quality products, ensuring that customers receive consistent and high-quality products and services.

Medium Manufacturing

CMC Guide System

Medium manufacturing

QuaCell Biotechnology strictly complies with the requirements of ISO9001:2015 Quality Management System, adopts PDCA cycle, and always risk-based thinking to manage the process and the entire quality system. We strictly control the five elements of "Human, Machine, Material, Law, and Environment" according to GMP to ensure product quality.

PDCA Cycle Model

Five management elements: Human, Machine, Material, Law and Environment (refer to GMP management requirements)

Customer requirements

Customer satisfaction

Organization and its environment

Quality Assurance

System results

Related parties

Needs and expectations

Products and services

Quality Policy

Establish a corporate image with product innovation
Win customer satisfaction with excellent quality

Complete Supplier Evaluation, Raw Material Management, and Audit System

Refer to GMP Standard Production Management

The whole process of dry powder production is strictly managed in accordance with the GMP standard of raw materials

Obtained ISO9001 Quality System Certification

The certificate is issued by SGS, an internationally renowned certification body

Logistics Chain Enterprise Resource Management (ERP)

ERP traceability records throughout the entire process from raw material procurement to finished product delivery

From the purchase of raw materials, production to the final product sales, the quality department is supervised and controlled to ensure that the entire process is "all things have rules to be followed, the law operates all things, all things are supervised, and all things are well documented."

Warehousing

Customer information protection

Confidential documents and related systems

Authority management

SKU customization

Supply guarantee and quality stability guarantee

Regular audit

Standby plant plan (branch plant in Yangtze River Delta region in 2021)

Third party contract

More extreme cases, discuss protection strategy with customers

Force majeure factors, such as earthquake, epidemic situation, etc

CMC guide system