
A complete QA/QC System is designed and being operated in accordance with cGMP procedures and requirements. The plants had obtained GMP certificates issued by the Sate Drug Administration (SDA). One plant had passed FDA inspections. Since the updated test instruments, the validated analytical methods as well as the professional operations are the foundation of quality assurance and quality control, a high level testing center with advanced instruments and professional analysts were installed and recruited.
|
Instrument |
Specs. |
Origin |
Quantity |
|
IR- spectrophotometer |
PE-863 Nexus-470 |
USA |
2 |
|
UV- spectrophotometer
|
|
China |
1 |
|
GC
|
SP-3700 |
China |
1 |
|
SQ-204 |
China |
1 |
|
SQ-206 |
China |
2 |
|
GC-17A |
Japan |
1 |
|
HPLC |
LC-6A |
Japan |
1 |
|
Sy5000 |
USA |
1 |
|
LC-10A |
Japan |
1 |
|
P200 |
China |
1 |
|
Potentiometric titrator |
ZD-2 |
China |
2 |
|
Granulometer |
Multisizer II |
USA |
1 |
|
Medicine dissolving-meter |
RC-601 |
China |
1 |
|
Analysis balance |
TG-328A |
China |
10 |

|