One article read the 2020 version of GMP Appendix 4 "Blood Products" key changes.

On July 3, 2020, the official website
of the State Drug Administration released a new revision of the GMP Appendix "Blood Products" released, which will come into effect from October 1, 2020, and the new version of "Blood Products" will contain seven chapters and 35 articles, reflecting the spirit of "four most severe"In order to implement the relevant requirements of the Vaccine Management Law and the Drug Administration Law, further strengthen the management of blood products, regulate the production and quality management behavior of blood products, this paper makes a comparative analysis of the new and old version of "Blood Products" mainly added revisions, the content of the article blue font for the new or modified content, the red font with the deletion line is deleted contentinterpretation: the new version of "Blood Products" a total of seven chapters and 35 articles, the addition of 1 article, revised 22 articles, unchanged 12 articles, the amendment of the provisions mainly around further strengthening the management of blood products, regulate the production and quality management of blood products behaviorInterpretation: The new version of "blood products" chapter 1 scope 4, on the basis of the old version of 4 have been revised, the revised provisions mainly around the definition of blood products and regulatory departments and so onInterpretation: The new version of "Blood Products" Chapter II Principle 1 clause, on the basis of the old version has been revised, the revised provisions mainly remove the pathogen exampleInterpretation: The new version of "Blood Products" Chapter 3 Person 5 clause, of which 2 articles on the basis of the old version of the amendment, 3 provisions remain unchanged, the revised provisions for the blood products enterprise key personnel (production management and quality management head) qualifications increased academic qualifications, titles and working years requirements, improve the industry access qualificationsInterpretation: The new version of "Blood Products" Chapter IV Plant and Equipment 6 Clauses, of which 2 articles on the basis of the old version of the amendment, 4 clauses remain unchanged, the revised provisions require blood products enterprises to have the enterprise production and quality requirements of the inspection capacityEnterprises should conduct regular laboratory capability assessments to ensure that the results of the experiment are accurate, reliable and true, accurate, complete and traceable in the recording of the inspection process information, thus improving the eligibility of the industryInterpretation: The new version of "Blood Products" Chapter V Raw Material Plasma 9 articles, 7 of which are modified on the basis of the old version, 2 articles remain unchanged, the revised provisions around the plasma acceptance inspection, validity, transportation and destruction managementInterpretation: The new version of "Blood Products" Chapter VI Production and Quality Control 9 articles, of which 5 articles on the basis of the old version of the amendment, 3 articles remain unchanged, the addition of 1 clause, the revised provisions around the production management of blood products, the new provisions mainly increased virus pollution and safety management requirementsInterpretation: The new version of "blood products" Chapter VII non-conforming raw materials plasma, intermediate products, finished products, the treatment of 1 clause, on the basis of the old version has been modified, the revised provisions clearly that the enterprise is the responsibility of this regulation.