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Bio-Pharmaceutical

The design basis for a GMP (Good Manufacturing Practice) cleanroom in the field of biopharmaceuticals

 

1) "Guidelines for Good Manufacturing Practices for Pharmaceutical Products" (Revised in 1992) by the Ministry of Health.

2) "Design Specifications for Cleanrooms in the Pharmaceutical Industry" (1997).

3) "Implementation Guidelines for Pharmaceutical Production Management Standards" (1992).

4) "Design Specifications for Cleanrooms" (1984).

5) "Design Specifications for Ventilation and Air Conditioning" (GBJ19-87).

6) "Management Standards for Non-woven Medical Device Production" (YV/T-0033-90).

7) Technical documentation provided by owners, including process layout drawings, and other related materials.


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