CN

innovation and internationalization

Quality Management

International Quality Care for Health

Qingdao Baiyang Pharmaceutical always puts drug quality first, actively introduces international advanced production equipment, testing instruments and cutting-edge technology, and has established a quality management system covering the entire drug production process. Production is carried out in accordance with international drug standards, quality standards and production processes approved by drug supervision and management departments, ensuring that the entire drug production process continues to meet the requirements of drug production quality management standards。

 

Qingdao Baiyang Pharmaceutical adheres to the mission of "optimizing medical scenarios through technological innovation", and is committed to improving drug accessibility, bringing greater health value to patients, and safeguarding human health by developing new drugs and improving production processes. Starting from the source control of each drug, through strict screening of raw materials, refined production process management, comprehensive quality testing, and rigorous product review and release, Qingdao Baiyang Pharmaceutical's care and protection for human health are reflected from the moment the drug reaches the hands of patients. In the future development, Qingdao Baiyang Pharmaceutical will continue to be driven by technological innovation and guided by patient needs, constantly improving its own strength and making greater contributions to the cause of human health。

Construction of international quality system

Build a quality system based on international quality specifications and current standards such as NMPA, FDA, ICH, WHO, PIC/S, ISPE, and continuously improve it. The company has always adhered to the concept of "Quality Comes from Design" (QbD) and continuously guided the team to adhere to the cornerstone of compliance with the "quality-oriented" quality culture for all employees. Ensure the continuous and efficient operation of the international high standard quality management system, committed to using technological innovation as the driving force, guided by patient needs, and making greater contributions to the cause of human health。

Quality system compliance history and continuous improvement

Since the first zero defect FDA inspection in 2016, it has continuously passed multiple on-site inspections by NMPA and FDA, as well as on-site audits by multiple cooperative clients every year. Among them, the FDA on-site inspection results in 2016 and 2024 were zero defects. The company insists on controlling risks through a sound quality management program, continuously improving based on regulatory compliance and customer orientation, and has gained high recognition from inspection experts and customers.