"GMP" is the acronym for Good Manufacturing Practice is a special emphasis on product quality and the implementation of the autonomy of health and safety management system in the production process. It is a set of mandatory standards applicable to the pharmaceutical, food and other industries requiring companies from raw materials, personnel, facilities, equipment, production process, packaging, transportation, quality control, according to the national laws and regulations to achieve health quality requirements, forming a operational The job specifications to help companies improve corporate environmental health, to discover problems in the production process, to be improved. Briefly, GMP requires manufacturers should have good equipment, reasonable production process, improve the quality of management and strict inspection system to ensure the quality of the final product meets regulatory requirements.
GMP workshop refers to the quality and safety management system in line with GMP requirements workshop.
all levels of airborne particulates standard
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maximum allowable RSP Xu number / m (a) |
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cleanliness level |
static (b) |
dynamic (b) |
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≥ 0.5μm (d) |
≥ 5μm |
≥ 0.5μm (d) |
≥ 5μm |
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A Class |
3500 |
1 (e) |
3500 |
1 (a) |
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B grade (c) |
3500 |
1 (e) |
350000 |
2000 |
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C grade (c) |
350000 |
2000 |
3500000 |
20000 |
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D grade (c) |
3500000 |
2,0000 |
not specified (f) |
not specified (f) |
Dynamic standard microbiological monitoring of clean areas
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planktonic bacteria |
settlement bacteria (90mm) |
surface microbes |
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level |
Cfu/m3 |
cfu / 4 小时 (b) |
contacts dish (55mm) cfu / dish |
5 mittens cfu / gloves |
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A Class |
<1 |
<1 |
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<1 |
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B Class |
10 |
5 |
5 |
5 |
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C Class |
100 |
50 |
25 |
- |
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D Class |
200 |
100 |
50 |
- |