Quality

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.

Named for a Chinese folk hero in the 11th century who was known for extreme honesty and uprightness during 25 years as a judge, BAOGONG® represents a new industry standard for remote quality control capabilities and CMO-client relationships. This novel quality control monitoring system is composed of two primary components:

  • Hitachi’s manufacturing execution software system for the pharmaceutical manufacturing
  • Live stream CCTV system in all manufacturing suites

Used in harmony, these features give PaizaBio clients strict control in reviewing, in real-time, the aseptic fill-and-finish of their drugs into final dosage forms and packaging via their laptop, PDA, or smart phone anywhere in the world.

The Hitachi HITPHAMS® MES software is customizable to capture both standard GMP and whatever instrument or environmental metric that the client specifies and allows for real-time monitoring as well as serving to capture all data during manufacturing, creating an auditable detailed record, serving to help prevent omissions in manufacturing records and transcription errors

To accommodate our global client base, BAOGONG® can be registered in the client’s language of choice.


BAOGONG® Global Observation and Navigation Guidance System At A Glance

  • Industry’s most comprehensive real-time digital and video quality control monitoring system
  • Strict production control centering on manufacturing instructions and results records
  • Live stream CCTV in all manufacturing suites
  • Controls SOP, confirms task
  • PDA/Smartphone compatible for real-time monitoring and record upload
  • Linked with manufacturing equipment
  • FDA 21 CFR Part 11 compatible (electronic recording and signature)
  • Easily searchable database of manufacturing
  • GQP compatible
  • Utilizes familiar MicroSoft® Excel format
  • Multi-language support function


PaizaBio’s BAOGONG® system redefines quality assurance for the global pharmaceutical industry. If you want complete confidence in your contract manufacturing partner in the sensitive area of aseptic fill-and-finish, you have it with PaizaBio. Contact Us for details.