Quality

We never forget that our business is about people and their health. We strive to deliver nothing less than exceptional quality in our processes, products and services, so that patients’ health is protected, the reputations of our clients remain intact, and ultimately, clients succeed in China’s dynamic marketplace.

PaizaBio has implemented a comprehensive, integrated quality control system that addresses four areas:

  • Exceptional project management
  • Aseptic processing and manufacturing environment
  • State-of-the-art customer project tracking via BAO-Gong®, real-time digital and video quality control monitoring system
  • Unparalleled commitment to training and continued education of our workforce and staff

Communication, responsiveness, and accountability are the foundation of our quality control. PaizaBio’s quality systems are implemented via Standard Operating Procedures and updated in accordance with regulatory requirements and industrial developments. We have a full complement of microbial and chemical testing activities for raw material, components, in process and finished goods. In addition to employing USP/EP methodologies and monographs, we accommodate client-specific methods.

Our sterile manufacturing model supports cGMP compliance requirements. Our Quality Assurance and Control group provides day-to-day oversight for sterile manufacturing operations, with regular audits by Chinese regulatory agencies, contract customers and our own internal auditing teams.

PaizaBio is home to the pharmaceutical industry’s most comprehensive real-time digital and video quality control monitoring system, which we call BAO-Gong. Built on Hitachi’s manufacturing execution software system for pharmaceutical manufacturing, BAO-Gong advances quality by empowering clients to participate in production monitoring.

PaizaBio is committed to the education and training of our team. We have invested millions of dollars in one of the pharmaceutical industry’s first full scale state-of-the-art aseptic processing management and training centers, The Sterile University, in Hangzhou, China. Internationally known and recognized training instructors in the field of aseptic processing lead courses for managers and front-line employees. Investing in our people keeps our team up to date, motivated and committed to quality.


BAOGONG®

Everything PaizaBio does is without compromise and with total focus on quality, integrity and accountability. Thus, we have implemented the pharmaceutical industry’s most comprehensive real-time remote management execution system. The Bioanalytical Operations Global Observation and Navigation Guidance System, BAO-Gong, enables clients anywhere in the world to monitor the manufacture of their product in real time just as if they were present in our operation suites.

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Quality is never a given. It demands our attention every day. Anything less is unacceptable to our customers and to those who rely on pharmaceuticals for their health. Contact Us to for Details.