on the principle that “quality is originated from design and formed in
production; Techdow dedicated to provide best service for public
health”, Techdow built and implement own quality management system which
conforms to China, Australia, EU and US GMP requirements.
has sufficient staffs of quality management, test instruments and
equipment, and documentation system to implement quality management
requirements. The quality department is the second large one after
production department. The documentation system has been built which has
over 3000 documents and procedures to ensure all activities in system
accord to existing procedures, and form corresponding records or report
to guarantee the running of system. Techdow has specialized staffs and
procedures to track and update the knowledge of advanced quality
management. In the audits and inspection, Techdow continued to improve
by achieving advanced idea of quality management. Techdow’s QC lab has
HPLC, GC, IR, Ion chromatography, ELIASA, TOC, Atomic absorption
spectrometric and near 200 advanced test equipment. Techdow has built
the most strict quality standard of Enoxaparin sodium of China and
executed data integrity management strictly.
quality management system has been inspected by CFDA, and more severe
institution like Australia TGA, EU GMP, US FDA. All inspections were
100% passed. Techdow has become the minority manufacturer of
non-terminal sterilized injection, also minority API manufacturer who
passed FDA inspection two successive times with zero deficiency.