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Quality System

Quality System

Based on product quality risk management, we follow NMPA, ICH, FDA and EU regulations and guidelines to establish a quality system that meets the requirements of life-cycle management of pharmaceutical products ensure regulatory compliance for product registration and declaration.


Guidelines of Quality Control

Establishing corporate image with product innovation, gaining customer satisfaction with qualified quality control.


PDCA Model


Production Management

Preventing multi-product collinear pollution and cross-contamination; avoiding confusion and error, to ensure data reliability in production systems.


Elements of quality assurance

Quality system suitable for pre-IND and clinical drug manufacturing stages.


Quality system documentation

More than 500 quality documents are in effect.
And over 600 records or templates are continuously being improved.