血液制品（Blood products）.doc

血液制品（Blood products） Appendix 4: Blood products Chapter 1 Scope Article 1 the blood products in this appendix refer to human plasma proteins. The provisions of this appendix apply to the production, quality control, storage, distribution and transportation of human blood products. Second the production of blood products in this appendix includes the whole process of receiving, storage, re examination, plasma separation, preparation of blood products and verification of finished products from raw materials, plasma, storage, examination, plasma separation, etc.. Third production of blood products with raw plasma collection, inspection, storage and transportation shall be in accordance with the Peoples Republic of China Pharmacopoeia blood products regulations with human plasma and the Ministry of health plasma collection stations quality management standards. The management of fourth blood products should also comply with relevant state regulations. Second chapter principle Fifth raw plasma may contain blood borne diseases by pathogens (such as HIV, HBV, HCV), in order to ensure the safety of the product, we must ensure the legitimacy of the quality and source of raw plasma, must strictly control the production process, especially the removal process and / or inactivated virus, must carry on quality control strict on raw materials and products. Third chapter personnel The sixth person in charge of the enterprise shall have the professional knowledge of blood products and shall be trained in relevant legal knowledge. The person in charge of the seventh production management shall have the corresponding professional knowledge (such as biology, microbiology, immunology, biochemistry, etc.) with at least three years engaged in the production of blood products or quality management experience. And the qualified person responsible for the eighth quality management shall have the corresponding professional knowledge (such as biology, microbiology, immunology, biochemistry, e