Quality Assurance
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Innovent's quality system complies with internationally recognized ISO and ICHQ10 standards, including GXP, China GMP regulations, CFR21 in the pharmaceutical product development and product realization part. Quality assurance covers the quality of the product throughout its life cycle in terms of management systems, management processes, product realization, monitoring and improvement, document management, and personnel training. High standard quality system runs through the whole process of material storage, sampling, inspection, use, to production, sampling, testing and releasing, ensuring the safety, stability and effectiveness of each batch of samples.

The enterprise has an independent quality management organization, the Quality Management Guarantee Department, which is responsible for the quality management of the enterprise. The QMS Quality System is implemented under the system, site, material, document control and compliance and audit department.

The Quality Management Department of Innovent consists of quality assurance, quality control, quality engineering, audit and compliance, through which a Quality Management System (QMS) is integrated throughout the company. Innovent has fully documents observations through deviations management, change control management, CAPA, risk management, lot release, quality monitoring, documentation and training programs. The Quality Management team leverages in depth domestic and international industry knowledge to ensure the execution and improvement of Innovent’s QMS.

 

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