QA&QC
UNIBEST aims for the same high standards in quality, environmental
protection and safety at all of its facilities. The company
is aligned and has introduced primarily centrally coordinated
management systems for quality and environmental protection.
These are audited and certified by external certification companies.
UNIBEST aims to provide pharmaceutical intermediates of high
purity, minimum impurity and consistently reliable quality by
using cutting-edge production processes and facilities as well
as stringent quality control.
Enhancing production facilities and boosting cGMP compliance
level.
UNIBEST produces pharmaceutical intermediates as per GMP standard
and made efforts to renovate existing production facilities,
especially isolated areas for final manufacturing steps including
centrifugation, drying, blending and packaging processes.
As a result, cGMP compliance level in the plants has been
greatly improved.
Improving quality control and organization of stronger
QA/QC unit
To meet the requirements of cGMP, we have established a stringent
QA/QC system, which forms the basis of our quality strategy.
Standard Operation Procedure (SOP) is established throughout
each production process, from raw material purchase and production
through to product distribution.
Quality standard and quality control
On the basis of physical and chemical characteristics, product
application and synthesis routes, a proper quality standard
system, test and analysis methods and quality control criteria
are established for each production process. In addition to
conventional physical and chemical analysis methods, we also
use the following analysis methods and apparatus for product
testing:
， Agilent HPLC G1354A 1200
， Agilent GC 6890
， IR & UV
， Optical Rotation & Specific Rotation
， Karl Fischer Water Titration
， Digital Instrument of Melting Point
， Bruker 500M NMR(SIOC)
， Vario El III Elemental Analyzer(SIOC)
， HPLC-MS spectrometer(SIOC)
， GC-MS spectrometer(SIOC)
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