 
 
'Good Manufacturing Practice' (1998) GMP will be divided into 100 clean rooms, 10,000, 100,000, 300,000 four grades, and sterile drugs, non-sterile drugs, drug raw materials, bio-products, traditional Chinese medicine Agents, such as the six major categories of its production and quality were put forward specific requirements.
|
GMP pharmaceutical cleanliness level |
The maximum allowable dust / m |
The maximum allowable number of micro-organisms |
|
≥0.5μm |
≥5μm |
Planktonic bacteria / m3 |
Settlement bacteria / m2 |
|
100级 |
3500 |
0 |
5 |
1 |
|
10000级 |
350000 |
2000 |
100 |
3 |
|
100000级 |
3500000 |
20000 |
500 |
10 |
|
300000级 |
10500000 |
60000 |
1000 |
15 |
|
