4.8.3¡¢Key for Quality Control

(1) Material and adjuvant should be according to the requirement of "china medical dictionary" or "china bio-products material quality standard".

(2) Producing water should be according to drinking water's standard. Purity water, injection water and sterilizing injection water should be according to the requirement of "china medical dictionary".

(3) Material plasma should be performed the following test: HBSAg, HIV-1/HIV-2 antigen, HCV antigen. The result should be negative. Placenta plasma should be tested for HBSAg, HIV-1/HIV-2 antigen, HCV antigen, syphilis. The result should be negative.

(4) Original liquid should be tested for the following items: remaining alcohol, protein content, purity, PH value, pyrogen.

(5)While semi-products' repacking, sample should be left for aseptic test after bacteria are removed.

(6) ach batch product should be sampled for complete test according to relative regulation. The reagent of HBSAg, HIV-1/HIV-2 antigen, HCV antigen should be approved by State Food and Drug Administration.