Shanghai Zerun Biotechnology Co.,Ltd


Quality Policy Statement

Quality is Zerun’s life and soul. We commit to providing high quality and reliable vaccines to the public.

We promise that:

---Promote a quality-first corporate culture
---Implement a quality mindset throughout every R&D and manufacturing processes
---Ensure effectiveness and continuous improvement of the quality management system
---Manufacture safe and efficacious vaccine products

Quality Management System (QMS)

The corporation strictly complies with all relevant laws and regulations. Using the concept of quality risk management and quality by design, we strive to achieve the goal of continuously improving product quality. We have established an integrated quality management system from product development to manufacturing. While each function area has its respective responsibilities, all functions are closely collaborating to ensure all systems run efficiently to ensure product quality, safety and efficacy.

The company has an independent Quality Unit reporting directly to the Chief Executive Officer. Using comprehensive document management systems, the company continuously improves the company’s quality management process. Quality control for research and development are managed through timely and complete documentation to ensure data and information accuracy, authenticity and integrity. Material procurement, storage, and use are strictly controlled. Master validation plans are developed and specific validation activities are carried out in organized manner to maintain compliance with regulatory requirements. Quality activities, such as change control and deviation are managed via risk based approach. Any breaches are adjusted and remedy measures are developed in a timely manner.