Bridge brings Chinese facilities up to Western standards

Bridge Pharmaceuticals, with the assistance of B-W Design Group and Instem, has successfully validated its Provantis data acquisition software for full FDA Part 11 Compliance.

Bridge's preclinical testing laboratory in Zhongguancun Life Science Park in Beijing, China has completed the first of two validation phases of all instrumentation, software and air handling and BMS systems. The state of the art facility, one of the largest and most advanced vivariums in China, is currently the only pre-clinical laboratory in China to have US level GLP validated systems and software.

'The validation of the instrumentation, air handling systems, environmental control systems and data acquisition software is a result of the tremendous effort and dedication of the management and staff of this facility along with the regulatory experts of B-W Design Group and Instem's Provantis validation team,' said Dr Ada Kung of Bridge. 'This completes a major step for Bridge's Beijing facility towards becoming the first and only US level GLP compliant preclinical laboratory in China.'

'Our team has worked interactively with the Bridge preclinical staff to assess a majority of the facility's systems and instruments for full Part 11 compliance,' commented Howard Treadaway, manager of regulatory services for B-W Design Group.

'Upon completion of the remaining systems and instruments during the second phase in December, 2006 Bridge's preclinical facility will meet Western standards and comply with FDA Good Laboratory Practices and 21 CFR Part 11. More importantly, Bridge Preclinical Staff will have the skills and quality systems to maintain a validated facility,' Treadaway added.